Label: LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 8, 2021

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  • Active ingredient

    Piperonyl butoxide 4%

    Pyrethrum extract (equivalent to 0.33% pyrethrins)

  • Uses

    treats head, pubic (crab), and body lice

  • Purpose

    Lice treatment

  • Warnings

    Do not use

    • near eyes
    • inside nose, mouth, or vagina
    • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

    Ask a doctor before use if you are

    • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

    When using this product

    • keep eyes tightly closed and protect eyes with a washcloth or towel
    • if product gets into eyes, flush with water right away
    • 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

    Keep out of reach of children

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

  • Directions

    Important: Read warnings before use
    Adults and children 2 years and over:

    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 this product

    Treat

    • apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.
    • allow product to remain for 10 minutes, but no longer
    • use warm water to form a lather, shampoo, then thoroughly rinse
    • for head lice, towel dry hair and comb out tangles

    Remove lice and their eggs (nits)

    • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
    • hair should remain slightly damp while removing nits
    • if hair dries during combing, dampen slightly with water
    • for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.
    • lift a 1-to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
    • pin back each strand of hair after combing
    • clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
    • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
    • check daily for any lice/nits that you missed
    • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
    • if infestation continues, see a doctor for other treatments

    Children under 2 years: ask a doctor

  • Other information

    • do not freeze
    • store at controlled room temperature 20°-25°C (68°-77°F)
    • to report serious side effects due to the use of this product call 515-276-1586
    • see package insert for additional information
  • Inactive ingredients

    ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

  • Package Insert

    InsertInsert

  • Principal Display Panel

    Carton

    LICE KILLING SHAMPOO

    For the treatment of Head Lice, Pubic (Crab) Lice and Body Lice

    DIRECTIONS

    Important: Read warnings before using this product. A second treatment must be done in 7-10 days to kill anu newly hatched lice eggs (nits)

    Inspect

    examine each household member with a magnifying glass in bright light for lice/eggs (nits)
    look for tiny eggs (nits) near scalp, beginning at the back of neck and behind ears
    examine small sections of hair
    eggs (nits) stick to the hair
    if either lice or eggs (nits) are found, treat with this product

    Treat

    apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck
    allow product to remain for 10 minutes but no longer
    use warm water to form a lather, shampoo, then thoroughly rinse
    for head lice, towel dry hair and comb out tangles

    To Remove Lice and Their Eggs (Nits)

    use a special lice/nit or fine-toothed comb (included). Remove any remaining eggs (nits) by hand, using a throwaway glove
    hair should remain slightly damp while removing eggs (nits)
    if hair dries during combing, dampen slightly with water
    for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours
    lift a 1- to 2-inch wide strand of hair. Place comb firm, even motion away from scalp
    pin back each strand of hair after combing
    clean comb often. Wipe eggs (nits) away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back
    after combing, thoroughly recheck for lice/eggs (nits). Repeat combing if necessary
    check daily for any lice/eggs (nits) that you missed
    a second treatment must be done within 7 to 10 days to kill any newly hatched lice/eggs (nits)
    if infestation continues, see a doctor for other treatments

    1. HEAD LICE

    head lice lay small white eggs (nits) on the hair shaft close to the scalp
    eggs (nits) are most easily found on the back of the neck or behind the ears
    disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes
    items that cannot be washed, dry cleaned or stored may be sprayed with a product designed for this purpose
    soak all combs and brushes in hot water [above 54 C (130 F)] for at least 10 minutes
    vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people

    2. PUBIC (CRAB) LICE

    pubic (crab) lice may be contracted by sexual contact
    sexual partners should be treated simultaneously to avoid reinfestation
    lice are very small and look like brown or grey dots on the skin
    pubic (crab) lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface
    pubic (crab) lice may be present on the short hairs of the groin, thighs, trunk, and underarms, -and occasionally on the beard, eyelids, and mustache
    disinfect underwear by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes

    3. BODY LICE

    body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit areas
    body lice feed on skin then return to clothing to lay their eggs (nits)
    disinfect clothing by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 mintues
    do not seal clothing in a plastic bag because eggs (nits) can remain dormant for up to 30 days

    Save this insert for future reference

  • INGREDIENTS AND APPEARANCE
    LICE KILLING 
    piperonyl butoxide, pyrethrum extract shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 g  in 100 mL
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
    Product Characteristics
    Coloryellow (Cloudy to transparent , cream to straw) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-310-021 in 1 CARTON05/17/2021
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G05/17/2021
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(11383-310)