Label: SKLICE- ivermectin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 13, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ivermectin 0.5%

  • Purpose

    Lice treatment

  • Use

    treats head lice

  • 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

    Stop use and ask a doctor if

    • breathing difficulty occurs
    • eye irritation occurs
    • skin or scalp irritation continues or infection occurs
    • rash develops

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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 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.

    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 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

    • store at room temperature 68°-77°F. Excursions permitted to 59°-86°F.
    • do not freeze
    • keep carton and see Consumer Information Leaflet and warnings before use
  • Inactive ingredients

    acetylated lanolin alcohol, cetyl acetate, citric acid, cyclomethicone, lanolin alcohol, methylparaben, oleyl alcohol, olive oil, polysorbate 80, propylparaben, shea butter, sodium citrate, sorbitan tristearate, and water

  • Questions?

    1-866-516-4950
    Monday – Friday: 9 am – 5 pm EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    arbor®
    PHARMACEUTICALS, LLC
    Atlanta, GA 30328

    Manufactured by:
    Jubilant HollisterStier
    General Partnership
    16751 Trans-Canada Highway
    Kirkland, Quebec,
    Canada H9H 4J4

  • PRINCIPAL DISPLAY PANEL - 117 g Tube Carton

    NDC 24338-185-04

    NEW!

    Sklice®
    Ivermectin Lotion 0.5%
    Lice Treatment

    Original Prescription
    Strength

    Now available without
    a prescription!

    One tube, one time,
    10 minutes!

    SKLICE KILLS LICE

    No nit combing required

    No second application
    required

    Includes:
    1 Tube
    Net Wt. 4 oz (117 g)

    PRINCIPAL DISPLAY PANEL - 117 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SKLICE 
    ivermectin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24338-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24338-185-041 in 1 CARTON08/01/2021
    1117 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20273608/01/2021
    Labeler - Arbor Pharmaceuticals (781796417)