Topical (Corticosteroids)

Low Potency  

Alclometasone diproprionate  (Aclovate ®)

DOSAGE AND ADMINISTRATION
Apply a thin film of ACLOVATE® Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

ACLOVATE® Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of ACLOVATE® Cream or Ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

ACLOVATE® Cream or Ointment should not be used with occlusive dressings unless directed by a physician. ACLOVATE® Cream or Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use: In studies where geriatric patients (65 years of age or older) have been treated with ACLOVATE® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Desonide  (DesOwen ® )

DOSAGE AND ADMINISTRATION
DesOwen® Cream, Ointment or Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

DesOwen® Cream, Ointment and Lotion should not be used with occlusive dressings.

Fluocinolone acetonide (Synalar ® )

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED SECTION
Fluocinolone Acetonide Cream 0.01% USP is supplied in: 15 g tubes NDC 0713-0223-15, 60 g tubes NDC 0713-0223-60
Fluocinolone Acetonide Cream 0.025% USP is supplied in: 15 g tubes NDC 0713-0222-15, 60 g tubes NDC 0713-0222-60
Fluocinolone Acetonide Ointment 0.025% USP is supplied in: 15 g tubes NDC 0713-0224-15, 60 g tubes NDC 0713-0224-60

Fluocinolone Acetonide Topical Solution 0.1%:
60 mL Bottle with applicator tip - NDC 52565-012-59

STORAGE AND HANDLING

Store at controlled room temperature 15°-30° C (59°-86° F).
Manufactured by: G & W Laboratories, Inc., 111 Coolidge Street, South Plainfield, N.J. 07080
Rev. 02/11 8-FLUOGW3

Hydrocortisone  (Hytone ®, Cortaid ®, other):

Supplied:
Cream/Spray/Ointment/Lotion- multiple strengths:  0.5%, 1%, 2.5%

Medium Potency  

Betamethasone dipropionate  (Diprosone ®)

INDICATIONS AND USAGE:
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS:
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (See DOSAGE AND ADMINISTRATION).

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See package insert - PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

• This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
• Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
• The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive.
• Patients should report any signs of local adverse reactions.
• Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings

DOSAGE AND ADMINISTRATION:
Apply a thin film of Betamethasone Dipropionate Cream or Ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary.

Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night.

If an infection develops, appropriate antimicrobial therapy should be instituted.

Betamethasone Dipropionate products should not be used with occlusive dressings.

HOW SUPPLIED:

betamethasone valerate:

CONTRAINDICATIONS:
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (See DOSAGE AND ADMINISTRATION).

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See package insert - PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

• This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
• Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
• The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive.
• Patients should report any signs of local adverse reactions.
• Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressing

DOSAGE AND ADMINISTRATION
Apply a thin film of Betamethasone Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.

Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.

HOW SUPPLIED

clocortolone pivalate (Cloderm ® )

Occlusive dressings may be used for the management of psoriasis orrecalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

HOW SUPPLIED
Clocortolone Pivalate Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45 gram and 90 gram tubes.

desoximetasone  (Topicort ® )

Apply a thin film of Desoximetasone Ointment, 0.25% to the affected skin area twice daily. Rub in gently.

HOW SUPPLIED

Desoximetasone Cream USP, 0.05% is supplied in 15 gram (NDC 51672-1271-1), 60 gram (NDC 51672-1271-3), 100 gram (NDC 51672-1271-7) tubes and 300 gram carton (3 × 100 gram tubes) (NDC 51672-1271-8).

Desoximetasone Cream USP, 0.25% is supplied in 15 gram (NDC 51672-1270-1), 60 gram (NDC 51672-1270-3), 100 gram (NDC 51672-1270-7) tubes and 200 gram carton (2 × 100 gram tubes) (NDC 51672-1270-9)

Desoximetasone Gel USP, 0.05% is supplied in 15 gram (NDC 51672-1261-1) and 60 gram (NDC 51672-1261-3) tubes.

Desoximetasone Ointment USP, 0.25% is supplied in
15 g tubes NDC 0168-0151-15
60 g tubes NDC 0168-0151-60

fluocinolone acetonide  (Synalar ® )

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED SECTION
Fluocinolone Acetonide Cream 0.01% USP is supplied in: 15 g tubes NDC 0713-0223-15, 60 g tubes NDC 0713-0223-60
Fluocinolone Acetonide Cream 0.025% USP is supplied in: 15 g tubes NDC 0713-0222-15, 60 g tubes NDC 0713-0222-60
Fluocinolone Acetonide Ointment 0.025% USP is supplied in: 15 g tubes NDC 0713-0224-15, 60 g tubes NDC 0713-0224-60

Fluocinolone Acetonide Topical Solution 0.1%:
60 mL Bottle with applicator tip - NDC 52565-012-59

STORAGE AND HANDLING

Store at controlled room temperature 15°-30° C (59°-86° F).
Manufactured by: G & W Laboratories, Inc., 111 Coolidge Street, South Plainfield, N.J. 07080
Rev. 02/11 8-FLUOGW3

flurandrenolide  (Cordran ® )

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Cordran® (flurandrenolide, USP) should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

TAPE:
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of Cordran Tape and other occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Replacement of the tape every 12 hours produces the lowest incidence of adverse reactions, but it may be left in place for 24 hours if it is well tolerated and adheres satisfactorily. When necessary, the tape may be used at night only and removed during the day.

If ends of the tape loosen prematurely, they may be trimmed off and replaced with fresh tape.

The directions given below are included for the patient to follow unless otherwise instructed by the physician.

HOW SUPPLIED
Cordran® Cream is supplied in aluminum tubes as follows:
Cordran® Cream, 0.025%:
30 g (NDC 16110-034-30)
60 g (NDC 16110-034-60)
120 g (NDC 16110-034-12)
Cordran® Cream, 0.05%:
15 g (NDC 16110-035-15)
30 g (NDC 16110-035-30)
60 g (NDC 16110-035-60)
120 g (NDC 16110-035-12)

Cordran® Ointment is supplied in aluminum tube as follows:
Cordran® Ointment, 0.05%:
15 g (NDC 16110-026-15)
30 g (NDC 16110-026-30)
60 g (NDC 16110-026-60)

Tape:
4 mcg/sq cm—small roll, 24 in x 3 in (60 cm x 7.5 cm)
NDC 52544-044-24

4 mcg/sq cm—large roll, 80 in x 3 in (200 cm x 7.5 cm)
NDC 52544-044-80

fluticasone propionate (Cutivate ® )

Atopic Dermatitis: Apply a thin film of CUTIVATE® Cream to the affected skin areas once or twice daily. Rub in gently.

Other Corticosteroid-Responsive Dermatoses: Apply a thin film of CUTIVATE® Cream to the affected skin areas twice daily. Rub in gently.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

CUTIVATE® Cream should not be used with occlusive dressings. CUTIVATE® Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

LOTION:
CUTIVATE® Lotion may be used in adult and pediatric patients 1 year of age or older. The safety and efficacy of CUTIVATE® Lotion in pediatric patients below 1 year of age have not been established (see PRECAUTIONS: Pediatric Use).

Atopic Dermatitis: Apply a thin film of CUTIVATE® Lotion to the affected skin areas once daily. Rub in gently.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of drug use for longer than 4 weeks have not been established.

CUTIVATE® Lotion should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

HOW SUPPLIED
CUTIVATE® (fluticasone propionate cream) Cream 0.05% is supplied in:
30-g tubes (NDC 10337-332-30), and
60-g tubes (NDC 10337-332-60).

CUTIVATE® Lotion is supplied in
60 mL bottle NDC 0462-0434-60
120 mL bottle NDC 0462-0434-04

hydrocortisone butyrate  (Locoid ® )

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Hydrocortisone Butyrate Topical Solution, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.

HOW SUPPLIED:
Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing:
5 g NDC 51672-4083-5 (as physician samples) 30 g NDC 51672-4083-2
10 g NDC 51672-4083-7 45 g NDC 51672-4083-6
15 g NDC 51672-4083-1

Hydrocortisone Butyrate Cream USP, 0.1% is supplied in tubes containing:
5 g NDC 51672-4074-5 (as physician samples) 30 g NDC 51672-4074-2
10 g NDC 51672-4074-7 45 g NDC 51672-4074-6
115 g NDC 51672-4074-1

Hydrocortisone Butyrate Topical Solution, 0.1% is supplied in polyethylene bottles containing:
20 mL NDC 51672-4061-2 60 mL NDC 51672-4061-4

hydrocortisone valerate  (Westcort ® )

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Hydrocortisone valerate cream USP, 0.2% or hydrocortisone valerate ointment USP, 0.2% should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate cream USP, 0.2% or hydrocortisone valerate ointment USP, 0.2% should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

HOW SUPPLIED

Hydrocortisone valerate cream USP, 0.2%, is supplied in 15 g (NDC 51672-1290-1), 45 g (NDC 51672-1290-6), 60 g (NDC 51672-1290-3) tube sizes.

Hydrocortisone valerate ointment USP, 0.2% is supplied in 15 g (NDC 51672-1292-1), 45 g (NDC 51672-1292-6), 60 g (NDC 51672-1292-3) tube sizes.

mometasone furoate  (Elocon ® )

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of ELOCON Cream in pediatric patients for more than 3 weeks of use have not been established.

ELOCON Cream should not be used with occlusive dressings unless directed by a physician. ELOCON Cream should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

ELOCON Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae.

LOTION:
Apply a few drops to the affected skin areas once daily and massage lightly until it disappears.
Discontinue therapy when control is achieved.
If no improvement is seen within 2 weeks, reassess diagnosis.
Do not use with occlusive dressings unless directed by a physician.

OINTMENT:
Apply a thin film to the affected skin areas once daily.
Discontinue therapy when control is achieved.
If no improvement is seen within 2 weeks, reassess diagnosis.
The safety and efficacy of ELOCON Ointment in pediatric patients for more than 3 weeks of use have not been established.
Do not use with occlusive dressings unless directed by a physician.

DOSAGE FORMS AND STRENGTHS

Cream, 0.1%. Each gram of ELOCON Cream contains 1 mg of mometasone furoate in a white to off-white smooth and homogenous cream base.

ELOCON Lotion, 0.1% (30 mL)

OINTMENT: ELOCON Ointment 0.1% is a white to off-white uniform ointment and supplied in 15-gram (NDC 0085-0370-01) and 45-gram (NDC 0085-0370-02) tubes; boxes of one.

prednicarbate  (Dermatop ® )

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP Emollient Cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

DERMATOP Emollient Cream 0.1% should not be used with occlusive dressings unless directed by the physician. DERMATOP Emollient Cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

OINTMENT:
Apply a thin film of DERMATOP Ointment 0.1% to the affected skin areas twice daily. Rub in gently.

HOW SUPPLIED
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supplied in 60 g (NDC 0066-0507-60) tubes.

DERMATOP Ointment (prednicarbate ointment) 0.1% is supplied in 60 gram (NDC 0066-0508-60) tubes.

triamcinolone (Aristocort ®, Kenalog ® )

DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

LOTION:
Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Triamcinolone Acetonide Cream USP, 0.1% is supplied in
15 g (0.53 oz) tubes
80 g (2.8 oz) tubes
453.6 g (1 lb) jars
2.268 kg (5 lb) jars

Triamcinolone Acetonide Ointment USP, 0.1% is supplied in
15 g (0.53 oz) tubes
80 g (2.8 oz) tubes

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL.

High Potency  

amcinonide  (Cyclocort ® )

Occlusive dressings may be a valuable therapeutic adjunct for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Amcinonide Topical Cream USP, 0.1% (1 mg/g) is supplied in 4 gm, 15 gm, 30 gm and 60 gm tubes.

Amcinonide Topical Ointment USP, 0.1% (1 mg/g) is supplied in 15 gm, 30 gm and 60 gm tubes.

Amcinonide Lotion, 0.1% is supplied as follows:
NDC 0168-0280-60 60 mL bottle

Store at 20° -25°C (68°-77°F) [see USP Controlled Room Temperature]

DO NOT FREEZE.

augmented betamethasone dipropionate (Diprolene ® )

Betamethasone dipropionate cream USP, 0.05% (augmented) is not to be used with occlusive dressings.

HOW SUPPLIED
Betamethasone dipropionate cream USP, 0.05% (augmented) is supplied in 15 g (NDC 51672-1310-1), 30 g (NDC 51672-1310-2) and 50 g (NDC 51672-1310-3) tubes.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

betamethasone dipropionate (Diprosone ® )

INDICATIONS AND USAGE:
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS:
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (See DOSAGE AND ADMINISTRATION).

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See package insert - PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

• This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
• Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
• The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive.
• Patients should report any signs of local adverse reactions.
• Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings

DOSAGE AND ADMINISTRATION:
Apply a thin film of Betamethasone Dipropionate Cream or Ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary.

Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night.

If an infection develops, appropriate antimicrobial therapy should be instituted.

Betamethasone Dipropionate products should not be used with occlusive dressings.

HOW SUPPLIED:

desoximetasone (Topicort ® )

Apply a thin film of Desoximetasone Ointment, 0.25% to the affected skin area twice daily. Rub in gently.

HOW SUPPLIED

Desoximetasone Cream USP, 0.05% is supplied in 15 gram (NDC 51672-1271-1), 60 gram (NDC 51672-1271-3), 100 gram (NDC 51672-1271-7) tubes and 300 gram carton (3 × 100 gram tubes) (NDC 51672-1271-8).

Desoximetasone Cream USP, 0.25% is supplied in 15 gram (NDC 51672-1270-1), 60 gram (NDC 51672-1270-3), 100 gram (NDC 51672-1270-7) tubes and 200 gram carton (2 × 100 gram tubes) (NDC 51672-1270-9)

Desoximetasone Gel USP, 0.05% is supplied in 15 gram (NDC 51672-1261-1) and 60 gram (NDC 51672-1261-3) tubes.

Desoximetasone Ointment USP, 0.25% is supplied in
15 g tubes NDC 0168-0151-15
60 g tubes NDC 0168-0151-60

diflorasone diacetate (Maxiflor ®)

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

OINTMENT:
ApexiCon® Ointment (diflorasone diacetate ointment USP 0.05%) should be applied to the affected area as a thin film from one to three times daily depending on the severity or resistant nature of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

HOW SUPPLIED

ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) is available in the following size tubes:
NDC 10337-395-30 30 gram tube
NDC 10337-395-60 60 gram tube 

ApexiCon® Ointment (diflorasone diacetate ointment USP 0.05%) is available in the following size tubes:
NDC 0462-0394-30 30 gram tube
NDC 0462-0394-60 60 gram tube

Store at controlled room temperature 15° to 30°C (59° to 86°F). Keep tightly closed.

fluocinolone acetonide (Synalar ® )

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED SECTION
Fluocinolone Acetonide Cream 0.01% USP is supplied in: 15 g tubes NDC 0713-0223-15, 60 g tubes NDC 0713-0223-60

Fluocinolone Acetonide Cream 0.025% USP is supplied in: 15 g tubes NDC 0713-0222-15, 60 g tubes NDC 0713-0222-60
Fluocinolone Acetonide Ointment 0.025% USP is supplied in: 15 g tubes NDC 0713-0224-15, 60 g tubes NDC 0713-0224-60

Fluocinolone Acetonide Topical Solution 0.1%:
60 mL Bottle with applicator tip - NDC 52565-012-59

STORAGE AND HANDLING

Store at controlled room temperature 15°-30° C (59°-86° F).
Manufactured by: G & W Laboratories, Inc., 111 Coolidge Street, South Plainfield, N.J. 07080
Rev. 02/11 8-FLUOGW3

fluocinonide  (Lidex ® )

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Fluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 51672-1253-1), 30 g (NDC 51672-1253-2), 60 g (NDC 51672-1253-3) and 120 g (NDC 51672-1253-4) tubes.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Fluocinonide Cream USP, 0.05% (Emulsified Base) is supplied in 15 g (NDC 51672-1254-1), 30 g (NDC 51672-1254-2) and 60 g (NDC 51672-1254-3) tubes.
Store at controlled room temperature. Avoid excessive heat, above 40°C (104°F).

Fluocinonide Gel USP, 0.05% is supplied in 15 g (NDC 51672-1279-1), 30 g (NDC 51672-1279-2) and 60 g (NDC 51672-1279-3) tubes.
Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature].

Fluocinonide Ointment USP, 0.05% is supplied in 15 g (NDC 51672-1264-1), 30 g (NDC 51672-1264-2) and 60 g (NDC 51672-1264-3) tubes.
Store at 20°-25°C (68°-77°F). Avoid temperature above 30°C (86°F).

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

halcinonide  (Halog ® )

Occlusive Dressing Technique
Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply HALOG under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

HALOG ® (Halcinonide Cream, USP) 0.1% is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is supplied as:
NDC 10631-094-20 Tubes containing 30 g
NDC 10631-094-30 Tubes containing 60 g
NDC 10631-094-76 Jars containing 216 g

HALOG® OINTMENT (Halcinonide Ointment, USP) 0.1% is supplied as tubes containing 15 g (NDC 10631-096-15), 30 g (NDC 10631-096-20), and 60 g (NDC 10631-096-30).

Storage
Store at room temperature; avoid excessive heat (104º F).

Very High Potency  

augmented betamethasone dipropionate (Diprolene ® )

Apply a thin film of Betamethasone Dipropionate Ointment (Augmented), 0.05% to the affected skin once or twice daily. Betamethasone Dipropionate Ointment (Augmented), 0.05% is a super-high potency topical corticosteroid. Treatment with Betamethasone Dipropionate Ointment (Augmented), 0.05% should be limited to 50 g per week.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Betamethasone Dipropionate Ointment (Augmented), 0.05% should not be used with occlusive dressings.

Betamethasone Dipropionate Ointment (Augmented), 0.05% should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

HOW SUPPLIED
Betamethasone Dipropionate Ointment (Augmented), 0.05 % is supplied in 15 g (0.53 oz), 45 g (1.59 oz) and 50 g (1.76 oz) tubes; boxes of one.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F) [see USP Controlled Room Temperature].

clobetasol propionate (Temovate ® )

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

DOSAGE AND ADMINISTRATION
Apply a thin layer of clobetasol propionate cream or ointment to the affected skin areas twice daily and rub in gently and completely.

Clobetasol propionate cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate cream and ointment should not be used with occlusive dressings.

Geriatric Use
In studies where geriatric patients (65 years of age or older) have been treated with clobetasol propionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
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FOAM:
Clobetasol Propionate Foam, 0.05% (Emulsion) is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of Clobetasol Propionate Foam, 0.05% (Emulsion) to the affected area(s) twice daily, morning and evening for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g. or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.

Limitations of Use
•Clobetasol Propionate Foam, 0.05% (Emulsion) should not be applied to the face, axillae, or groin.
•Clobetasol Propionate Foam, 0.05% (Emulsion) should not be used if there is skin atrophy at the treatment site.
•Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.

HOW SUPPLIED
Clobetasol Propionate Cream, USP, 0.05% is supplied in 15-g tubes (NDC 50383-267-15), 30-g tubes (NDC 50383-267-30), 45-g tubes (NDC 50383-267-45), and 60-g tubes (NDC 50383-267-60).

Clobetasol Propionate Ointment, USP, 0.05% is supplied in 15-g tubes (NDC 50383-268-15), 30-g tubes (NDC 50383-268-30), 45-g tubes (NDC 50383-268-45), and 60-g tubes (NDC 50383-268-60).

Clobetasol Propionate Foam, 0.05% (Emulsion) is supplied as follows:
50 g aluminum can NDC 45802-637-32
100 g aluminum can NDC 45802-637-33

diflorasone diacetate  (Psorcon ®)

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

OINTMENT:
Topical corticosteroids should be applied to the affected area as a thin film from one to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated

HOW SUPPLIED
Psorcon E Emollient Cream is available in the following size tubes:
15 gram NDC 0066-0272-17
30 gram NDC 0066-0272-31
60 gram NDC 0066-0272-60

Psorcon E Emollient Ointment is available as follows:
15 gram tube NDC 0066-0275-17
30 gram tube NDC 0066-0275-31
60 gram tube NDC 0066-0275-60

Store at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].

halobetasol propionate (Ultravate ® )

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

CONTRAINDICATIONS
Halobetasol Propionate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

DOSAGE AND ADMINISTRATION
CREAM:
Apply a thin layer of Halobetasol Propionate Cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Halobetasol Propionate Cream is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Halobetasol Propionate Cream should not be used with occlusive dressings.

OINTMENT:
Apply a thin layer of Halobetasol Propionate Ointment, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Halobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Halobetasol propionate ointment should not be used with occlusive dressings.

HOW SUPPLIED

Halobetasol Propionate Cream, 0.05% is supplied in the following tube sizes:
15 g (NDC 0713-0640-15)
50 g (NDC 0713-0640-86)

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:
15 g
50 g

STORAGE
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].