Topical Antifungals

INDICATIONS AND USAGE
Mentax® (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare). Butenafine HCl cream was not studied in immunocompromised patients.

CONTRAINDICATIONS
Mentax® (butenafine HCl) Cream, 1%, is contraindicated in individuals who have known or suspected sensitivity to Mentax® Cream, 1%, or any of its components.

WARNINGS
Mentax® (butenafine HCl) Cream, 1%, is not for ophthalmic, oral, or intravaginal use.

DOSAGE AND ADMINISTRATION
Patients with tinea (pityriasis) versicolor should apply Mentax® Cream, 1%, once daily for two weeks. Sufficient Mentax® Cream should be applied to cover affected areas and immediately surrounding skin of patients with tinea versicolor. If a patient shows no clinical improvement after the treatment period, the diagnosis and therapy should be reviewed.

HOW SUPPLIED
Mentax® (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:
15-gram tube (NDC 0378-6151-46)
30-gram tube (NDC 0378-6151-49)
STORE BETWEEN 5° and 30°C (41° and 86°F).
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

CONTRAINDICATIONS
Ciclodan® Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS
Ciclodan® Cream is not for ophthalmic use.

Keep out of reach of children.

DOSAGE AND ADMINISTRATION
CREAM: Gently massage Ciclodan® Cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with Ciclodan® Cream the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

GEL: Superficial Dermotophyte Infections - Gently massage ciclopirox gel 0.77% into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for four weeks. If a patient shows no clinical improvement after four weeks of treatment, the diagnosis should be reviewed. Seborrheic Dermatitis of the Scalp -Apply ciclopirox gel 0.77% to affected scalp areas twice daily, in the morning and evening for four weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. If a patient shows no clinical improvement after four weeks of treatment, the diagnosis should be reviewed.

HOW SUPPLIED
Ciclodan® Cream is available as follows:
90 g tube (NDC 43538-520-90)
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Manufactured for: Medimetriks Pharmaceuticals, Inc.
363 Route 46 West, Fairfield, NJ 07004

Ciclopirox Gel 0.77% is supplied in:
NDC 0168-0407-30 30 gram tube
NDC 0168-0407-46 45 gram tube
NDC 0168-0407-99 100 gram tube
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Other:
Ciclopirox Topical Solution, 8%, (Nail Lacquer)

Purpose
Antifungal

Uses
cures most athlete's foot, jock itch, and ringworm
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings
For external use only
Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoid contact with the eyes.

Stop use and ask a doctor if:
irritation occurs.
there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
wash affected area and dry thoroughly.
apply a thin layer over affected area twice daily (morning and night).
supervise children in the use of this product.
for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails

Other information
store between 20° to 25°C (68° to 77°F)

PRINCIPAL DISPLAY PANEL - 24 g Tube Carton
LOTRIMIN®AF
clotrimazole cream

Foam:Ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.

CONTRAINDICATIONS:
Econazole Nitrate Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

WARNINGS:
Econazole Nitrate Cream, 1% is not for ophthalmic use.

ADVERSE REACTIONS:
During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging and erythema. One case of pruritic rash has also been reported.

DOSAGE AND ADMINISTRATION:
Sufficient Econazole Nitrate Cream 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.

Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

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Foam:
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Ecoza topical foam, 1% is for topical use only. Ecoza topical foam, 1% is not for oral, ophthalmic, or intravaginal use.
Ecoza topical foam, 1% should be applied to cover affected areas once daily for 4 weeks.

HOW SUPPLIED:
Econazole Nitrate Cream 1% is supplied as follows:

NDC 0168-0312-15 15 gram tube
NDC 0168-0312-30 30 gram tube
NDC 0168-0312-85 85 gram tube
Store Econazole Nitrate 1% Cream below 86°F (30°C).
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Foam, 1%. Each gram of Ecoza topical foam, 1%, contains 10 mg of econazole nitrate in a white to off-white foam.

CONTRAINDICATIONS:
None.

ADVERSE REACTIONS:
The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DOSAGE AND ADMINISTRATION:
Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.

HOW SUPPLIED:
JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution supplied in a white plastic bottle with an integrated flow-through brush applicator as follows:

4 mL (NDC 0187-5400-04)
8 mL (NDC 0187-5400-08)

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SHAMPOO:
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Ketoconazole 2% shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

CONTRAINDICATIONS:
Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

WARNINGS:
Ketoconazole cream, 2% is not for ophthalmic use.

ADVERSE REACTIONS:
During clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol.

DOSAGE AND ADMINISTRATION:
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CREAM:
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Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor.
It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence.

Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.

Seborrheic dermatitis
Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
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SHAMPOO:
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Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.

One application of the shampoo should be sufficient.

HOW SUPPLIED:
Ketoconazole cream, 2% is supplied in 15 g (NDC 51672-1298-1), 30 g (NDC 51672-1298-2), and 60 g (NDC 51672-1298-3) tubes.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
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Ketoconazole 2% shampoo is a red-orange liquid supplied in a 4-fluid ounce (120 mL) nonbreakable plastic bottle (NDC 10147-0750-4).

?INDICATIONS:? Proven clinically effective in the treatment athlete's foot, jock itch and ringworm. Treats superficial skin infections caused by yeast. For effective relief of redness, irritation, itching, and burning.

?Directions?
-clean the affected area and dry thoroughly
-apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
-supervise children in the use of this product

?Athlete's Foot?
-pay special attention to the spaces between toes
-wear well-fitting, ventilated shoes and change shoes and socks at least once daily

?Athlete's Foot and Ringworm?
use daily for 4 weeks

?Jock Itch?
use daily for 2 weeks

This product is not effective on scalp or nails.

SUPPLIED:
Miconazole nitrate 2% [Cream, powder, spray]

1. Efficacy for this organism in this organ system was studied in fewer than 10 infections.

CONTRAINDICATIONS:
Naftin® Cream and Gel, 1% are contraindicated in individuals who have shown hypersensitivity to any of their components.

WARNINGS:
Naftin® Cream and Gel, 1% are for topical use only and not for ophthalmic use.

ADVERSE REACTIONS:
During clinical trials with Naftin® Cream, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%). During clinical trials with Naftin® Gel, 1%. the incidence of adverse reactions was as follows: burning Istinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).

DOSAGE AND ADMINISTRATION:
A sufficient quantity of Naftin® Cream, 1% should be gently massaged into the affected and surrounding skin areas once a day. A sufficient quantity of Naftin® Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day, in the morning and evening. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftin® Cream or Gel, 1%, the patient should be re-evaluated.

HOW SUPPLIED:

Naftin® (naftifine hydrochloride) Cream. 1% is supplied in collapsible tubes in the following sizes:
60g – NDC 0259-4126-60
90g – NDC 0259-4126-90

Naftin® (naftifine hydrochloride) Gel, 1% is supplied in collapsible tubes in the following sizes:
40g – NDC 0259-4770-40
60g – NDC 0259-4770-60
90g – NDC 0259-4770-90

CONTRAINDICATIONS:
Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.

WARNINGS:

ADVERSE REACTIONS:
Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration.

If irritation on topical application should occur, discontinue medication.

DOSAGE AND ADMINISTRATION:
Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder.

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
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Nystatin Ointment USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
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Nystatin Powder: Very moist lesions are best treated with the topical dusting powder.
Adults and Pediatric Patients (Neonates and Older):
Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

HOW SUPPLIED:
Nystatin Cream USP 100,000 units/g
15 g tube (0.53 oz)
30 g tube (1.1 oz)
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Nystatin Ointment USP 100,000 units/g
15 g tube (0.53 oz)
30 g tube (1.1 oz)
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Nystatin Topical Powder, USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles.
NDC 42543-052-61 for 15 g.
NDC 42543-052-62 for 30 g.
NDC 42543-052-63 for 60 g.

OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.

CONTRAINDICATIONS:
OXISTAT® Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.

WARNINGS:
OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% are not for ophthalmic or intravaginal use.

ADVERSE REACTIONS:
During clinical trials, of 955 patients treated with oxiconazole nitrate cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).

In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion, 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each).

DOSAGE AND ADMINISTRATION:
OXISTAT® Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. OXISTAT® Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

HOW SUPPLIED:
OXISTAT® (oxiconazole nitrate) Cream, 1% is supplied in:
30-g tubes (NDC 10337-358-30),
60-g tubes (NDC 10337-358-60), and
90-g tubes (NDC 10337-358-90).

Store between 15° and 30° C (59° and 86° F).

OXISTAT® (oxiconazole nitrate) Lotion, 1% is supplied in:
30-mL bottle (NDC 10337-359-30)
60-mL bottle (NDC 10337-359-60).

Uses
cures most athlete's foot (tinea pedis)
cures most jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, burning, cracking and scaling which accompany these conditions

Warnings
For external use only

Do not use:
on nails or scalp
in or near the mouth or the eyes
for vaginal yeast infections

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if too much irritation occurs or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions
-adults and children 12 years and older
-use the tip of the cap to break the seal and open the tube
-wash the affected skin with soap and water and dry completely before applying
-for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
-between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
-on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
-for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
-wash hands after each use
-children under 12 years: ask a doctor

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Spray:
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Directions

-adults and children 12 years and over
-wash the affected area with soap and water and dry completely before applying
-to open remove clear cap.
-hold can 4" to 6" from skin. Press and hold to spray a thin layer over affected area
-spray affected area once a day (morning or night) for 1 week or as directed by a doctor
-release to stop spray
-wipe excess from spray opening after each use
-return cap to can
-wash hands after each use
-children under 12 years: ask a doctor

Purpose
Antifungal

Uses:
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
With daily use, helps prevent most athlete's foot and helps keep it from coming back.
For relief of itching or chaffing associated with jock itch, itchy, scaly skin between the toes or itching, burning feet.

Warnings
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoid contact with eyes

Stop use and consult a doctor if
irritation occurs
there is no improvement within 4 weeks (in the case of athlete's foot or ringworm) or within 2 weeks (in the case of jock itch).

Directions:
Supervise children in the use of this product
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
For the treatment or prevention of athlete's foot: Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and ringworm: Use daily for 2 weeks. If the condition lasts longer, consult a doctor.
For jock itch: Use daily for 2 weeks. If the condition lasts longer, consult a doctor.
To prevent athlete's foot: Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
This product is not effective on the scalp or nails.

INDICATIONS AND USAGE:
KERYDIN (tavaborole) topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

CONTRAINDICATIONS:
None.

ADVERSE REACTIONS:
Common adverse reactions occurring in >/=1% in subjects treated with KERYDIN included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Anacor Pharmaceuticals at 1-844-4ANACOR [1-844-426-2267] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:
Apply KERYDIN to affected toenails once daily for 48 weeks.
KERYDIN should be applied to the entire toenail surface and under the tip of each toenail being treated.
KERYDIN is for topical use only and not for oral, ophthalmic, or intravaginal use.

HOW SUPPLIED:
KERYDIN (tavaborole) topical solution, 5% is a clear, colorless solution supplied in a 12-mL amber glass bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly.

KERYDIN (tavaborole) topical solution, 5% is supplied in the following presentation:

NDC 55724-111-11: One bottle containing 10 mL of solution with one glass pointed-tip dropper

Storage and Handling
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
CAUTION: Flammable. Keep away from heat and flame.
Discard product within 3 months after insertion of the dropper.
Keep bottle tightly closed. Keep out of reach of children.

CONTRAINDICATIONS:

WARNINGS:

ADVERSE REACTIONS:

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED: