Label: RID LICE KILLING- piperonyl butoxide and pyrethrum extract shampoo

  • 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 August 8, 2019

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

  • Drug Facts

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Piperonyl butoxide (4%)

    Pyrethrum extract (equivalent to 0.33% pyrethrins)

  • PURPOSE

    Purpose

    Lice treatment

  • Uses

    Uses treats head, pubic (crab), and body lice

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    · near the eyes

    · inside the nose, mouth, or vagina

    · on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

    · if you have ever had an allergic reaction to this product or any of its ingredients

  • ASK DOCTOR

    Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

  • WHEN USING

    When using this product

    ● keep eyes tightly closed and protect eyes with a washcloth or towel

    ● if product gets in eyes, flush with water right away

    ● scalp itching or redness may occur

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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 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.

  • Other information

    Other information

    ● keep carton for important product information

    ● see Consumer Information Insert for additional information

    ● avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredients ammonium laureth sulfate, dehydrated alcohol, fragrance, isopropyl alcohol, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water

  • Questions or comments

    Questions or comments? 1-800-RID-LICE (1-800-743-5423) www.ridlice.com

  • Consumer Information

    Consumer insert englishConsumer insert Spanish

  • PRINCIPAL DISPLAY PANEL

    RID

    LICE KILLING

    SHAMPOO

    LICE TREATMENT

    • Proven, effective treatment
    • Shampoo and conditioner in one
    • The RID comb is proven 100% effective for removing lice
    • East-to-follow illustrated instructions

    Champu' RID

    exterminador

    de piojos

    Se incluyen

    instructiones en espanol

    24/7

    SUPPORT

    CALL AN EXPERT

    1-800-RID-LICE

    HOW-TO VIDEOS

    ridlice.com

    Includes

    two combs

    8 FL OZ (236 mL)

    2 RID LICE COMBS

    Label 8 oz.

  • INGREDIENTS AND APPEARANCE
    RID LICE KILLING 
    piperonyl butoxide and pyrethrum extract shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-9000
    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
    PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
    POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-9000-021 in 1 CARTON03/01/2010
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0280-9000-041 in 1 CARTON03/01/2010
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0280-9000-061 in 1 CARTON03/01/2010
    3177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-9000-081 in 1 CARTON03/01/2010
    4237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G03/01/2010
    Labeler - Bayer HealthCare LLC. (112117283)