Label: CVS 3 STEP LICE SOLUTION- piperonyl butoxide, pyrethrum extract kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 13, 2020

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)
    • 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

    Consumer Information - Package Insert

    English

    Insert English

    Spanish

    Insert Spanish

  • Principal Display Panel

    CVS Health

    Compare to the Active Ingredients in RID® Shampoo†

    MAXIMUM STRENGTH

    3-Step Lice Solution Kit

    PROVEN EFFECTIVE TREATMENT

    • Works fast to kill lice
    • Helps children return to school "lice free"

    CAUTION: KEEP OUT OF REACH OF CHILDREN

    Instrucciones en español incluidas

    SHAMPOO 4 FL OZ (118 mL)

    COMBING SPRAY 2 FL OZ (59mL)

    LICE SPRAY NET WT 5 OZ (142g)

    1 NIT REMOVAL COMB

    Carton

  • INGREDIENTS AND APPEARANCE
    CVS 3 STEP LICE SOLUTION 
    piperonyl butoxide, pyrethrum extract kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-255
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-255-021 in 1 CARTON; Type 0: Not a Combination Product01/03/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 1 of 1
    LICE KILLING 
    piperonyl butoxide, pyrethrum extract shampoo
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE40 mg  in 1 mL
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT3.3 mg  in 1 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
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G02/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35810/28/2010
    Labeler - CVS (062312574)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(69842-255)