Label: LICE TREATMENT- permethrin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated 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 01/13

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

  • Active ingredient (in each fluid ounce)

    Permethrin 280 mg (1%)

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  • Purpose

    Lice treatment

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  • Uses

    treats head lice

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  • 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. (1-800-222-1222)

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  • Directions

    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 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
    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 (eggs) are found, treat with the 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 the creme rinse. Rinse with water.
    towel dry hair so it is damp but not wet
    shake the bottle well
    completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck.
    keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel.
    leave the creme rinse 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
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  • Other information

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

    abies balsamea (balsam canada) extract, anhydrous citric acid, butylparaben, ceteth-10, cetyl alcohol, ethylparaben, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose, isopropyl alcohol, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearalkonium chloride

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  • Questions or comments?

    1-800-719-9260

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  • Consumer Information

    Permethrin Lotion, 1%

    Lice Treatment Creme Rinse

    THE FACTS OF LICE

    Please read all information before using Lice Treatment 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 the creme rinse

    I. Inspect

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

    Inspect image #1

    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 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
    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 (eggs) are found, treat with the creme rinse.
    Inspect Image #2

    Treat Image

    II. 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 the creme rinse. Rinse with water.
    towel dry hair so it is damp but not wet
    shake the bottle well
    completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck.
    keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel.
    leave the creme rinse 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

    III. Remove Lice/Nits

    Treatment kills lice but does not remove the 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
    Remove Image

    IV. Clean home and personal items

    After using the 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.

    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, spray with lice control spray.
    vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.
    Clean Image

    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. (1-800-222-1222)

    Questions or comments?

    1-800-719-9260

    perrigo
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  • Principal Display Panel

    PERMETHRIN LOTION 1%

    Lice Treatment Creme Rinse

    With a single application kills lice & their eggs

    Prevents reinfestation for 14 days

    Approved for use on children over 2 months of age

    Compare to Nix® active ingredient

    Lice Treatment Creme Rinse Carton
    Lice Treatment Creme Rinse Carton image 2
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  • INGREDIENTS AND APPEARANCE
    LICE TREATMENT 
    permethrin lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0955
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PERMETHRIN (PERMETHRIN) PERMETHRIN 1 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BALSAM FIR LEAFY TWIG  
    ANHYDROUS CITRIC ACID  
    BUTYLPARABEN  
    CETETH-10  
    CETYL ALCOHOL  
    ETHYLPARABEN  
    FD&C YELLOW NO. 6  
    ISOPROPYL ALCOHOL  
    METHYLPARABEN  
    PHENOXYETHANOL  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    STEARALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0955-26 2 in 1 CARTON
    1 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076090 07/15/2010
    Labeler - Walgreen Company (008965063)
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