Label: BABY- talc powder

  • NDC Code(s): 0363-0901-04, 0363-0901-15, 0363-0901-22
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL

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 13, 2020

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  • ACTIVE INGREDIENT

    Active ingredient

    Talc 100%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses
    Keeps skin soft, fresh & comfortable.

  • WARNINGS

    Warnings

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • SPL UNCLASSIFIED SECTION

    Close tightly after use.

    Do not use on broken skin.

    Avoid contact with eyes.

    Keep powder away from child’s face to avoid inhalation, which can cause breathing problems.

  • DOSAGE & ADMINISTRATION

    Directions

    Shake powder into your hand and smooth onto skin.

  • STORAGE AND HANDLING

    Storage

    Store in a cool, dry place.

  • INACTIVE INGREDIENT

    Inactive ingredient

    Fragrance

  • SPL UNCLASSIFIED SECTION

    Package/Label Principal Display Panel

    Baby Powder

    Keeps skin soft, fresh & comfortable

    Clinically Tested

    NET WT 4 OZ (113 g)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BABY 
    talc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0901-04113 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    2NDC:0363-0901-15425 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    3NDC:0363-0901-22623 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34707/17/2014
    Labeler - Walgreen Company (008965063)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(0363-0901)
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