Topical (Antiparasitics)

DOSAGE AND ADMINISTRATION:
Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.

Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.

Supplied: [cream/lotion 10%]  LOTION: Shake well before using

USE IN SPECIFIC POPULATIONS
Safety and effectiveness in pediatric patients below the age of 6 months have not been established.

DOSAGE AND ADMINISTRATION::
-For topical use only. Not for oral, ophthalmic or intravaginal use.
-Apply SKLICE Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp.
-After 10 minutes, rinse off with water.
-For single use. Discard any unused portion.

DOSAGE FORMS AND STRENGTHS::
Lotion: 0.5%

CONTRAINDICATIONS::
None.

WARNINGS AND PRECAUTIONS
Accidental ingestion in pediatric patients may occur: Administer only under direct adult supervision.

ADVERSE REACTIONS
Most common adverse reactions (incidence <1%) are conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.

TTo report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur, Inc. at 1-800-835-3592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:  USE ONLY AS DIRECTED. DO NOT EXCEED RECOMMENDED DOSAGE.

No residual effects of lindane treatment have been demonstrated, therefore, this product should not be used to ward off a possible infestation. However, sexual contacts should be treated simultaneously.

Note: PLEASE READ CAREFULLY.

DIRECTIONS FOR USE
Warning: THIS PRODUCT CAN BE POISONOUS IF MISUSED. CHILDREN MUST NOT BE ALLOWED TO APPLY THIS DRUG WITHOUT DIRECT ADULT SUPERVISION. USE LOTION FOR SCABIES ONLY. APPLY ONLY ONCE. USE ONLY ENOUGH TO COVER THE BODY IN A THIN LAYER. 1 OUNCE (HALF OF A 2 OUNCE CONTAINER) SHOULD BE ALL THAT IS NEEDED FOR CHILDREN UNDER 6 YEARS OF AGE 1 TO 2 OUNCES FOR OLDER CHILDREN AND ADULTS. DO NOT LEAVE ON FOR MORE T.A. 12 HOURS. DO NOT INGEST. KEEP A.A. FROM MOUTH AND EYES. COVER INFANT'S HANDS AND FEET DURING TREATMENT TO PREVENT SUCKING AND LICKING OF LOTION. DO NOT USE IF OPEN WOUNDS, CUTS OR SORES ARE PRESENT, UNLESS DIRECTED BY YOUR PHYSICIAN.

(Lotion: Shake Well)
1. Apply this preparation to dry skin in a thin layer and rub in thoroughly.
2. Trim nails and apply under nails with toothbrush (throw away toothbrush after use).
3. If a warm bath is taken before application allow the skin to dry and cool completely before applying the medication.
4. A total body application should be made from the neck down, including soles of feet, unless otherwise directed by your physician.
5. The lotion should be left on for 8 to 12 hours (usually overnight) and then removed by thorough washing (bath or shower).
6. Avoid unnecessary contact with your skin if you are applying to another person. If treating more than one person, person applying lotion (especially pregnant or nursing women) should wear rubber gloves.
7. All recently worn clothing, underwear and pajamas, and used sheets, pillow cases, and towels should be washed in very hot water or dry cleaned.

After one application, itching will continue for several weeks. This is normal and does not require reapplication. If you have any questions or concerns about your condition or use of the lotion, contact your physician.

DOSAGE AND ADMINISTRATION:  Adults and children: Thoroughly massage ELIMITE® into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple and forehead. ONE APPLICATION IS GENERALLY CURATIVE.
Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

Head Lice (Nix rinse, lotion - 1%): After hair has been washed with shampoo, rinsed with water and towel dried, apply a sufficient volume of creme rinse to saturate the hair and scalp. Also apply behind the ears and at the base of the neck. Leave on hair for 10 minutes before rinsing off with water. Remove remaining nits. May repeat in 1 week if lice or nits still present. In areas of head lice resistance to 1% permethrin, 5% permethrin has been applied to clean, dry hair and left on overnight (8-14 hours) under a shower cap.

Supplied: Cream: Elimite®: 5%. Liquid creme rinse: (Nix®): 1% (60 ml). Lotion: 1% (59 ml). Spray [for bedding and furniture]: A200® Lice: 0.5% (180 ml). Nix®: 0.25% (148 ml). Rid®: 0.5% (150 ml).

DOSING:
Steps to Success With RID:

Step 1: Apply product
1] Apply RID Shampoo to DRY hair.
2] Thoroughly massage product into scalp, behind ears and onto back of neck.
3] Allow product to remain on hair for 10 minutes.
4] RID Shampoo: Lather with warm water and then rinse.
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Step 2: Comb
Comb with a wide-toothed comb to remove any tangles.
Note: When using RID Shampoo, try RID Lice and Egg Comb-out Kit to make combing easier

Carefully comb the ENTIRE head using the RID comb. (This process may be time consuming.)
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Step 3: Treat the home
All washable items should be washed in HOT water (130º F) and dried at HIGH temperatures.

Nonwashable items (eg, furniture) can also be treated to help prevent reinfestation.
Note: To treat nonwashable items in your home, consider RID Home Lice Control Spray.
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FOR RID SHAMPOO, STEPS 1 AND 2 MUST BE REPEATED IN 7–10 DAYS. SEE PACKAGE INSERT.
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Application of pyrethrins:
Topical products:

-Apply enough solution to completely wet infested area, including hair.
-Allow to remain on area for 10 minutes.
-Wash and rinse with large amounts of warm water.
-Use fine-toothed comb to remove lice and eggs from hair.
-Shampoo hair to restore body and luster.
-Treatment may be repeated if necessary once in a 24-hour period.
-Repeat treatment in 7-10 days to kill newly hatched lice.

Note: Keep out of eyes when rinsing hair; protect eyes with a wash cloth or towel.

SUPPLIED:
Foam, topical [mousse] (RID®): Pyrethrum extract 0.33% and piperonyl butoxide 4% (156 g)

Gel (Tisit® Blue Gel): Pyrethrum extract 0.33% and piperonyl butoxide 3% (30 g)

Liquid, topical (Tisit®): Pyrethrum extract 0.33% and piperonyl butoxide 2% (60 mL, 120 mL)

Shampoo: Pyrethrum extract 0.33% and piperonyl butoxide 4% (60 mL, 120 mL)

A-200® Maximum Strength: Pyrethrum extract 0.33% and piperonyl butoxide 4% (60 mL, 120 mL) [contains benzyl alcohol]

Solution, spray [for furniture, garments, bedding; not for human or animal use] (Tisit®): Pyrethrum extract 0.4% and piperonyl butoxide 2% (150 mL)

Adjunctive Measures
NATROBA Topical Suspension should be used in the context of an overall lice management program:

Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels.
Wash personal care items such as combs, brushes and hair clips in hot water
A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

DOSAGE AND ADMINISTRATION
-For topical use only. Not for oral, ophthalmic, or intravaginal use.
-Shake bottle well.
-Apply product to dry scalp and hair using only the amount needed to cover the scalp and hair.
-Rinse off with warm water after 10 minutes.
-Repeat treatment if live lice are seen 7 days after first treatment.
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For topical use only. NATROBA Topical Suspension is not for oral, ophthalmic, or intravaginal use.

Shake bottle well. Apply sufficient NATROBA Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off NATROBA Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.

HOW SUPPLIED
NATROBA (spinosad) Topical Suspension, 0.9% is a slightly opaque, light orange colored, viscous liquid, supplied in 4 oz (120 mL) high density polyetheylene (HDPE) bottles. NDC 52246-929-04

Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Keep out of reach of children