Label: NIX LICE KILLING CREME RINSE- permethrin rinse

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 7, 2022

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  • Drug Facts

  • Active ingredient (in each fluid ounce)

    Permethrin 280 mg (1%)

    Purpose

    Lice treatment

  • Uses

    treats head lice

  • Warnings

    For external use only

    Do not use

    • on children under 2 months of age
    • near the eyes
    • inside the nose, ear, mouth, or vagina
    • on lice in eyebrows or eyelashes.
      See your doctor.

    Ask a doctor before use if you are

    allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

    When using this product

    • keep eyes tightly closed and protect eyes with a washcloth or towel
    • if product gets into the eyes, immediately flush with large amounts of water
    • scalp itching or redness may occur

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    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

    • Adults and children 2 months old and older

    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 scalp, beginning at the back of the neck and behind the ears
    • small sections of hair (1-2 inches wide) should be examined at a time
    • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched,
    • if either lice or nits (or eggs) are found, treat with Nix ® Creme Rinse

    Treat

    • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix ®. Rinse with water.
    • towel dry hair so it is damp but not wet
    • shake the bottle of Nix ® well
    • completely saturate the hair and scalp with Nix ®. Begin to apply Nix ® behind the ears and at the back of the neck.
    • keep Nix ® out of the eyes. Protect the eyes with a washcloth or towel.
    • leave Nix ® on the hair for 10 minutes, but no longer
    • rinse with warm water
    • towel dry hair and comb out tangles
    • if live lice are seen seven days or more after the first treatment, a second treatment should be given

    Remove Lice/Nits

    • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
    • use the nit comb provided and make sure the hair remains slightly damp while removing nits
    • if the hair dries during combing, dampen it slightly with water
    • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
    • start at the top of the head on the section you have picked
    • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
    • use clips to pin back each strand of hair after you have combed out the nits
    • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
    • after combing, recheck the entire head for nits and repeat combing if necessary
    • check the affected head daily to remove any nits that you might have missed
  • Other information

    • read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    canada balsam, cetyl alcohol, citric acid, FD&C yellow no. 6, hydrolyzed animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene 10 cetyl ether, propylene glycol, propylparaben, stearalkonium chloride, water

  • Questions or comments?

    call 1-888- LICE (1-888-542-3546).

    Monday to Friday, 9 AM - 5 PM EST

  • Package Labeling:

    Label0Label02

  • INGREDIENTS AND APPEARANCE
    NIX LICE KILLING CREME RINSE 
    permethrin rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63471-3006(NDC:63736-030)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANADA BALSAM (UNII: K304VI98I3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (Light Orange) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63471-3006-21 in 1 CARTON11/15/2013
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01991811/15/2013
    Labeler - Geodis Logistics LLC (877844097)