Label: SKLICE- ivermectin lotion
- NDC Code(s): 24338-185-04
- Packager: Arbor Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated May 13, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only. Use only on the scalp.
Do not use
- on children under 6 months of age
- near the eyes
- inside the nose, ear, mouth, or vagina
- on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
Ask a doctor before use if you
- have any skin conditions or sensitivities
- are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby.
- are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby.
When using this product
- keep eyes tightly closed and protect eyes with a washcloth or towel
- if product gets into eyes, gently flush with water
- eye redness, soreness, or irritation can occur
- dandruff, dry skin, or burning sensation of the skin can occur
Stop use and ask a doctor if
- breathing difficulty occurs
- eye irritation occurs
- skin or scalp irritation continues or infection occurs
- rash develops
Important: Read warnings before use
- children 6 months of age to under 12 years of age: an adult should supervise use
- adults and children 6 months of age and over:
- all household members should be checked by another person for lice and/or nits (eggs)
- use a magnifying glass in bright light to help you see the lice and/or nits (eggs)
- use a tool, such as a comb or two unsharpened pencils to lift and part the hair
- look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
- examine small sections of the hair (1-2 inches wide) at a time
- unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
- if either lice or nits (eggs) are found, treat with product
- your hair and scalp must be DRY before applying product
- use the top of cap to break the tamper seal on the tube
- apply product directly to dry hair and scalp
- completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair
- use only amount to completely cover hair and scalp, up to 1 entire tube, and discard the remaining
- rub product throughout your hair
- it is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.
Wait and rinse
- allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with product.
- after 10 minutes, rinse product completely from your hair and scalp using only water
- after rinsing, dry and style as usual. Wait 24 hours before applying shampoo.
- wash your hands after applying product
- nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nits
- this is a single use product. Discard tube after use.
- do not use again on the same person and same lice infestation without talking to a healthcare provider first
- if infestation continues, see a doctor for other treatments
- machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.
- after finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 117 g Tube Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24338-185 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN 5 mg in 1 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) olive oil (UNII: 6UYK2W1W1E) oleyl alcohol (UNII: 172F2WN8DV) polysorbate 80 (UNII: 6OZP39ZG8H) cetyl acetate (UNII: 4Q43814HXS) lanolin alcohols (UNII: 884C3FA9HE) cyclomethicone (UNII: NMQ347994Z) shea butter (UNII: K49155WL9Y) sodium citrate, unspecified form (UNII: 1Q73Q2JULR) sorbitan tristearate (UNII: 6LUM696811) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) citric acid monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24338-185-04 1 in 1 CARTON 08/01/2021 1 117 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA202736 08/01/2021 Labeler - Arbor Pharmaceuticals (781796417)