Label: DR. WALTONS BABY POWDER- talc powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 21, 2012

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF CHILDREN'S REACH. AVOID BABY'S EYES, NOSE AND MOUTH.

  • PURPOSE

    GREAT FOR YOUR BABY: PREVENTS AND SOOTHES DIAPER RASH, ELIMINATES ODOR. USE AFTER EVERY BATH AND DIAPER CHANGE.

    GREAT FOR YOU: USE DAILY FOR SOFT, IRRITATION-FREE SKIN. REDUCES CHAFING AND ABSORBS MOISTURE. GREAT FOR ELIMINATING SAND AND MOISTURE AFTER A DAY AT THE BEACH!


  • DO NOT USE

    CAUTION: KEEP OUT OF CHILDREN'S REACH. AVOID BABY'S EYES, NOSE AND MOUTH. NOT FOR USE ON BROKEN SKIN. IF IRRITATION DEVELOPS, PLEASE DISCONTINUE USE.

    HYPOALLERGENIC; DERMATOLOGIST AND ALLERGY TESTED; PEDIATRICIAN TESTED

  • WARNINGS

    IF IRRITATION DEVELOPS, PLEASE DISCONTINUE USE.

  • INDICATIONS & USAGE

    PREVENTS AND SOOTHES DIAPER RASH, ELIMINATES ODOR

  • DOSAGE & ADMINISTRATION

    SHAKE POWDER ONTO HANDS AND GENTLY RUB ONTO SKIN

  • INACTIVE INGREDIENT

    TALC

  • ACTIVE INGREDIENT

    VITAMIN E (ALPHA-TOCOPHEROL), ZINC OXIDE

  • PRINCIPAL DISPLAY PANEL

    image of front label image of back labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    DR. WALTONS   BABY POWDER
    talc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76271-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL5.2 g  in 675 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.13 g  in 675 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76271-001-24675 g in 1 BOTTLE, PLASTIC
    2NDC:76271-001-0255 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34707/09/2011
    Labeler - Dr. Waltons, Incorporated (041377104)
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