Label: NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION- permethrin

  • NDC Code(s): 63736-024-02, 63736-027-06
  • Packager: Insight Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/13

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

  • SPL UNCLASSIFIED SECTION

    Creme Rinse

    Drug Facts

    Close
  • Active ingredient (in each fluid ounce)

    Permethrin 280 mg (1%)

    Close
  • Purpose

    Lice treatment

    Close
  • Uses

    treats head lice

    Close
  • 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 right away.

    Close
  • Directions

    Important: Read warnings before use:

    • Adults and children 2 months old and older

    Inspect

    • check each household member with a magnifying glass in bright light for lice/nits (eggs)
    • look for tiny nits near scalp, beginning at back of neck and behind ears
    • examine small sections of hair at a time
    • unlike dandruff which moves when touched, nits stick to the hair
    • if either lice or nits 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
    Close
  • 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)
    Close
  • Inactive ingredients

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

    Close
  • SPL UNCLASSIFIED SECTION

    Combing Gel

    Close
  • 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 right away

    Close
  • Directions

    • Use after shampooing with lice killing Nix creme rinse. When you finish combing, rinse hair thoroughly with warm water. Nix Combing Gel does not kill lice and nits. Read all the directions in the Consumer Information Insert before use.
    Close
  • ACTIVE INGREDIENT

    Ingredients

    purified water, propylene glycol, glycerin, polyquaternium-10, diazolidinylurea, hydroxyethyl cellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by Insight Pharmaceuticals Corp. 900 Northbrook Drive, Suite 200 Trevose, PA 19053-8433

    Close
  • MEDICATION GUIDE

    Nix®
    PERMETHRIN

    Lice Treatment Creme Rinse

    THE
    FACTS
    OF LICE

    Please read all information before using Nix® Creme Rinse.

    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

    Because nits (eggs) hatch in about one week, all nits must be removed to stop lice.

    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 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?

    • do not share or borrow personal items like combs, brushes, or headbands
    • do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animals
    • store hats in coat sleeves and hang coats separately, so that they do not touch other people's hats and coats
    • wash under fingernails when you first see lice or nits (eggs)
    • check your child's head daily when you hear of a lice outbreak in day care or school

    How to use NIX® Creme Rinse?

    Inspect

    If you suspect head lice - check. Head lice may be hard to locate because they avoid light. Nits are easier to see.

    Figure
    • check each household member with a magnifying glass in bright light for lice/nits (eggs)
    • look for tiny nits near scalp, beginning at back of neck and behind ears
    • examine small sections of hair at a time
    • unlike dandruff which moves when touched, nits stick to the hair
    • if either lice or nits 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
    Figure
    • 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
    Treatment kills lice but does not remove the nits.

    • remove nits by combing the hair with the premium comb provided. Remaining nits may be removed by hand (using a throw- away glove), or cutting the nits out.
    Figure
    • 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

    Clean home and personal items

    After using Nix® Creme Rinse, it is very important to clean personal items and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about 1 day.

    Figure
    • all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130°F), then dried in the dryer using the hottest cycle for at least 20 minutes
    • personal combs, including nit combs, and brushes should be soaked in hot water (above 130°F) for at least 10 minutes
    • personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in a plastic bag for a period of at least 4 weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again.
    • for anything you cannot wash, dry-clean or store in a plastic bag, use a lice control spray.
    • vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.
    Figure

    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 see 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 right away.

    Questions or comments?
    call 1-888-LICE LINE (1-888-542-3546),
    Monday to Friday, 9 AM - 5 PM EST

    www.nixlice.com

    Distributed by:
    INSIGHT Pharmaceuticals, LLC.
    Trevose, PA 19053-8433

    61-16-360B
    © 2013

    Close
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Nix®
    PERMETHRIN

    Have questions?
    Call our expert hotline
    888.542.3546

    PEDIATRICIAN RECOMMENDED
    #1
    TREATMENT

    Safe for use on children over 2 months old

    COMPLETE Maximum Strength
    Lice Elimination Kit

    BONUS!
    LICE CONTROL
    SPRAY INCLUDED

    Includes
    Exclusive Lice
    Removal &
    Hair Detangler
    Comb

    Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH,
    Combing Gel 2 fl oz (59 mL), Lice Comb

    nixlice.com

    Principal Display Panel - Kit Carton
    Close
  • INGREDIENTS AND APPEARANCE
    NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION 
    permethrin kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63736-027
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63736-027-06 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 BOTTLE 118 mL
    Part 2 1 BOTTLE 59 mL
    Part 1 of 2
    NIX 
    permethrin shampoo
    Product Information
    Item Code (Source) NDC:63736-024
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Permethrin (Permethrin) Permethrin 560 mg  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    canada balsam  
    cetyl alcohol  
    anhydrous citric acid  
    FD&C yellow no. 6  
    ceteth-10  
    propylene glycol  
    stearalkonium chloride  
    water  
    isopropyl alcohol  
    methylparaben  
    propylparaben  
    Product Characteristics
    Color ORANGE (Light Orange) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63736-024-02 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019918 06/05/2009
    Part 2 of 2
    NIX 
    tonics, dressings, and other hair grooming aids gel
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR water  
    INGR propylene glycol  
    INGR glycerin  
    INGR polyquaternium-10 (1000 MPA.S at 2%)  
    INGR diazolidinyl urea  
    INGR trisodium citrate dihydrate  
    INGR citric acid monohydrate  
    INGR methylparaben  
    INGR propylparaben  
    INGR edetate disodium  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 11/15/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019918 11/15/2013
    Labeler - Insight Pharmaceuticals (176792315)
    Close