Label: NIX COMPLETE LICE TREATMENT- permethrin kit

  • NDC Code(s): 63471-3006-2, 63471-3008-5, 63471-3020-0
  • Packager: Geodis Logistics LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 7, 2022

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

  • 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

  • Active ingredient:

    PERMETHRIN 0.25%

    Other ingredients: 99.75%

    100.00%

  • SPL UNCLASSIFIED SECTION

    NOT FOR USE ON HUMANS. READ ENTIRE LABEL BEFORE EACH USE. SHAKE BOTTLE WELL BEFORE USING.

    Precautionary Statements

    HAZARDS TO HUMANS AND DOMESTIC ANIMALS

    CAUTION User Safety Recommendations: Wear long-sleeved shirt and long pants, socks and shoes. User should wash hands before eating, drinking, chewing gum, using tocacco, or using the toilet. User should remove clothing immediately if persticide gets inside. Then wash thoroughly and put on clean clothing.

    Directions For Use

    It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

    Use Restrictions:For use as a surface spray, do not allow adults, children or pets to enter until sprays have dried. Do not apply as a broadcast treatment to indoor surfaces at residential sites, including nurseries, day care centers, schools, hospitals and nursing homes.

    FOR USE IN NON-FOOD AREAS INDOORS AND OUTSIDE PREMISES OF HOMES, HOBBY GREENHOUSES AND STORAGE BUILDINGS, CAMPERS, MOBILE HOMES, AUTOMOBILES, TRUCKS AND BOATS.

    INDOOR APPLICATIONS: In the home, cover all food handling surfaces, cover or remove all food and cooking utensils or wash thoroughly after treatment. Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application. Do not enter or allow others to enter until sprays have dried.

    Surface Spraying: To kill lice and louse eggs: Treat only those garments and parts of bedding, including mattresses and furniture, that cannot be either laundered or dry cleaned. Spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Spray from a distance of 8 to 10 inches. Allow all treated articles to dry thoroughly before use.

    To kill bedbugs:Spray mattresses lightly, particularly around tufts and seams. Take beds apart and spray in all joints. Allow all sprayed articles to dry thoroughly before use.

  • Storage & Disposal

    Pesticide Storage: Keep from freezing. Store upright at room temperature. out of reach of children and pets. Pesticide Disposal: If partly filled - Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. Container Handling: If empty - Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available.

    NOTICE: To the extent consistent with applicable law, buyer assumes all risks of use, storage or handling of this product not in stirct accordance with directions given herewith.

    EPA REG. NO. 64321-1-75406

    EPA EST. NO. 91705-NJ-001

  • Uses

    to detangle and comb the hair

  • Warnings

    For external use only. Avoid contact with the eyes

    Keep out of reach of children.

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

  • Directions

    • use after shampooing with lice killing creme rinse
    • towel dry hair
    • apply combining gel until all the hair and scalp is thoroughly wet with product
    • make sure product covers the area behind the ears and at the nape of the neck where there are more likely to be nits
    • part hair into sections and clip back
    • use the enclosed special-toothed comb to comb out dead lice and nits
    • comb out one section at a time
    • it is extremely important to comb out dead lice and nits
    • if hair begins to dry, reapply additional product
    • when you finish combing, rinse hair thoroughly with warm water.
  • Other Information

    • Nix Combing Gel does not kill lice and nits
    • Pesticide free
    • Keep carton for full information and warnings. Read all warnings and directions before use.
    • Visit our website at nixlice.com
  • Ingredients

    water, propylene glycol, glycerin, polyquaternium-10, diazolidinyl urea, hydroxyethylcellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

  • Package Labeling:63471-3020-0

    Kit3KitKit2

  • INGREDIENTS AND APPEARANCE
    NIX COMPLETE LICE TREATMENT 
    permethrin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63471-3020(NDC:63736-035)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63471-3020-01 in 1 KIT11/15/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BOTTLE 118 mL  in 2 
    Part 21 BOTTLE 147.86 mL
    Part 1 of 2
    NIX LICE KILLING CREME RINSE 
    permethrin rinse
    Product Information
    Item 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 CARTON
    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
    Part 2 of 2
    NIX LICE KILLING 
    permethrin spray
    Product Information
    Item Code (Source)NDC:63471-3008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63471-3008-51 in 1 CARTON
    1147.86 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01991811/15/2013
    Labeler - Geodis Logistics LLC (877844097)