Label: IVERMECTIN lotion

  • NDC Code(s): 51672-4230-8
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 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 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 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

    • TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN.
    • store at room temperature 68º-77ºF (20º-25ºC)
    • do not freeze
    • keep carton and see Consumer Information Leaflet and warnings before use
  • 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?

    1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals
    U.S.A., Inc.

    Hawthorne, NY 10532

  • Ivermectin Lotion, 0.5%Lice Treatment Lotion

    THE FACTS OF LICE

    Please read all information before using Ivermectin Lotion.

    If you or a member of your household has head lice, don't panic. Keep calm.

    Anyone can get head lice – it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems.

    What are head lice?

    • Head lice are small insects that live and feed on the human scalp.
    • They may get as big as sesame seeds and are brown.
    • Lice do not fly or jump from one person to another. They can only crawl.

    What are nits?

    • Nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits.
    • Nits are oval shaped, tiny and greyish-white.
    • They are attached to hair with a waterproof glue-like substance that cannot be washed out or blown away.

    How do head lice spread?

    • Head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice.
    • They may also be spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothing.

    How do you know if you have lice?

    • Itching is the most common symptom.
    • Scratching behind the ears or the back of the neck is a sign that you should check for head lice.
    • Scabs or blood spots may be seen.

    How do you prevent the spread of lice?

    • Avoid direct head-to-head contact with anyone known to have live, crawling lice.
    • Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
    • Avoid sleepovers and slumber parties during lice outbreaks.
    • Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.

    How do I use Ivermectin Lotion?

    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.
    Figure A

    figure A

    • Use the top of cap to break the tamper seal on the tube
      (see Figure A).
    • Apply product directly to dry hair and scalp (see Figure B).
    • Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair (see Figure C).
    • Use only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remaining.
    • Rub product throughout your hair (see Figure D).
    Figure B

    figure B

    Figure C

    figure C

    Figure D

    figure D

    • 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 (see Figure E).
    • After 10 minutes, rinse product completely from your hair and scalp using only water (see Figure F).
    Figure E

    figure E

    Figure F

    figure F

    • 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.

    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.

    Questions or comments? Call 1-866-923-4914

    Mfd. by: Taro Pharmaceutical Industries Ltd.
    Haifa Bay, Israel 2624761
    Made in Israel

    Issued: November 2020

  • PRINCIPAL DISPLAY PANEL - 117 g Tube Carton

    Compare to the
    active ingredient
    in Sklice®

    NDC 51672-4230-8

    Ivermectin
    Lotion, 0.5%
    Lice Treatment

    Original Prescription Strength

    Now available without
    a prescription!

    One tube, one time,
    10 minutes!

    IVERMECTIN LOTION 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
    IVERMECTIN 
    ivermectin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-4230
    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
    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
    ColorWHITE (off-white;tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-4230-81 in 1 CARTON01/06/2021
    1117 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072005/06/2020
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-4230)