Label: LICE TREATMENT - permethrin lotion 

  • Label RSS
  • NDC Code(s): 0472-5242-67, 0472-5242-69
  • Packager: Actavis Mid Atlantic LLC
  • 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 07/11

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

  • ACTIVE INGREDIENT

    Active ingredient (in each fluid ounce)

    Permethrin 280 mg (1%)

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  • PURPOSE

    Lice treatment

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  • USE

    Treats head lice

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  • WARNINGS

    For external use only

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  • 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.
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  • ASK A DOCTOR BEFORE USE IF YOU ARE

    • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.
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  • 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
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  • STOP USE AND SEE A DOCTOR IF

    side effects occur.

    breathing difficulty occurs

    eye irritation occurs

    • skin or scalp irritation continues or infection occurs
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

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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 Permethrin Lotion 1%

    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 Permethrin Lotion 1%. Rinse with water.
    • towel dry hair so it is damp but not wet
    • shake the bottle of Permethrin Lotion 1% well
    • completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.
    • keep Permethrin Lotion 1% out of the eyes. Protect the eyes with a washcloth or towel.
    • leave Permethrin Lotion 1% 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)
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  • INACTIVE INGREDIENTS

    Balsam fir canada, cetyl alcohol, citric acid, FD&C yellow #6, fragrance, hydrolyzed

    animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene

    10 cetyl ether, propylene glycol, propylparaben, purified water, stearalkonium chloride

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  • QUESTIONS?

    1-800-432-8534 (select option # 2) between 9 am and 4 pm EST, Monday – Friday.

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  • PRINCIPAL DISPLAY PANEL

    NDC 0472-5242-67

    Single Application

    Lice Treatment

    Permethrin Lotion 1%

    With A Single Application:

    • Kills Lice & Their Eggs
    • Prevents Reinfestation for 14 Days

      Creme Rinse With Nit Removal Comb

      2 FL OZ (59 mL)

      T:\Maryland\NJ\Juan\Permethrin Lotion\ANDA 075014\JPEG\5242_1.jpg
      T:\Maryland\NJ\Juan\Permethrin Lotion\ANDA 075014\JPEG\5242_2.jpg

      LICE TREATMENT CARTON LABEL

    Information for Patients

    Consumer Information Insert

    Permethrin Lotion 1%

    Lice Treatment

    Please read all information before using Permethrin Lotion 1%.

    If you or a member of your household has 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 Permethrin Lotion 1%

      1. Inspect

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

    • 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.
      T:\Maryland\NJ\Juan\ANDA 075014\mother-n-child.jpg
      T:\Maryland\NJ\Juan\ANDA 075014\childs-head.jpg

      PICTURE OF MOTHER CHECKING FOR LICE

    • if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%
      1. 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 Permethrin Lotion 1%. Rinse with water.
    • towel dry hair so it is damp but not wet
    • shake the bottle of Permethrin Lotion 1% well
    • completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.
    • keep Permethrin Lotion 1% out of the eyes. Protect the eyes with a washcloth or towel.
    • leave Permethrin Lotion 1% 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
      T:\Maryland\NJ\Juan\ANDA 075014\child-shampoo.jpg

      PICTURE OF CHILD WITH SHAMPOO ON HAIR

      1. 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
      T:\Maryland\NJ\Juan\ANDA 075014\child-comb.jpg

      PICTURE SHOWING HOW TO COMB HAIR

      1. Clean home and personal items

        After using Permethrin Lotion 1%, 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 a product that kills lice
    • vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.
      T:\Maryland\NJ\Juan\ANDA 075014\mom-laundry.jpg

      PICTURE OF MOTHER CLEANING

      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? 1-800-432-8534 (select option # 2).

    Form No. 5242-PI

    Rev. 8/08

    VC 3202

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  • INGREDIENTS AND APPEARANCE
    LICE TREATMENT 
    permethrin lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0472-5242
    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
    CANADA BALSAM  
    CETYL ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    FD&C YELLOW NO. 6  
    ISOPROPYL ALCOHOL  
    METHYLPARABEN  
    CETETH-10  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    STEARALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-5242-67 1 in 1 CARTON
    1 59 mL in 1 BOTTLE
    2 NDC:0472-5242-69 2 in 1 CARTON
    2 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075014 03/28/2010
    Labeler - Actavis Mid Atlantic LLC (809515898)
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