Label: WALGREENS LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo

  • NDC Code(s): 0363-1253-02, 0363-1253-04, 0363-1253-08
  • Packager: Walgreens CO
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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

  • Active ingredient

    Piperonyl butoxide 4%

    Pyrethrum extract (equivalent to 0.33% pyrethrins)

  • Uses

    treats head, pubic (crab), and body lice

  • Purpose

    Lice treatment

  • Warnings

    For external use only

    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

    Insert

  • Principal Display Panel

    Principal Display PanelWalgreens

    LICE KILLING SHAMPOO

    LICE TREATMENT SHAMPOO FOR HUMAN USE


    Maximum Strength
    Compare to RID® LICE KILLING SHAMPOO

    2 fl oz (59ml)

  • INGREDIENTS AND APPEARANCE
    WALGREENS LICE KILLING 
    piperonyl butoxide, pyrethrum extract shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1253
    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
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
    PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    Product Characteristics
    Coloryellow (cloudy to transparent, cream to straw) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1253-021 in 1 CARTON02/21/2019
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-1253-081 in 1 CARTON02/25/2019
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-1253-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03102/21/2019
    Labeler - Walgreens CO (008965063)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(0363-1253)