Label: IVERMECTIN lotion
- NDC Code(s): 82392-200-04
- Packager: Oystershell Consumer Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
-
Warnings
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
-
Directions
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:
Inspect
- 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
Treat
- your hair and scalp must be DRYbefore 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 needed 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 an 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
After treatment
- 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 heathcare 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
butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 117 g Tube Carton
-
INGREDIENTS AND APPEARANCE
IVERMECTIN
ivermectin lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82392-200 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 BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CASTOR OIL (UNII: D5340Y2I9G) CETYL ALCOHOL (UNII: 936JST6JCN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) IMIDUREA (UNII: M629807ATL) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) OLEYL ALCOHOL (UNII: 172F2WN8DV) OLIVE OIL (UNII: 6UYK2W1W1E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) SORBITAN TRISTEARATE (UNII: 6LUM696811) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Product Characteristics Color white (off-white;tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82392-200-04 1 in 1 CARTON 08/02/2024 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 OTC Monograph Drug ANDA210720 08/02/2024 Labeler - Oystershell Consumer Health, Inc. (117628199)
