Label: HEALTH SMART BABY- talc powder

  • NDC Code(s): 52862-010-13, 52862-010-14, 52862-010-15, 52862-010-16, view more
    52862-010-17, 52862-010-18
  • Packager: Home Smart Products
  • 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 August 13, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Talc 100%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    For Babies: Use after every bath and diaper change to make your baby’s skin soft and smooth. Helping to keep your baby happy and comfortable.

    For Adults: Use after bath or shower to keep your skin fresh and comfortable. Helps eliminate friction to keep skin from becoming irritated.

  • WARNING

    Warning

    For external use only. Avoid contact with eyes discontinue if irritation developes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

    Children if swallowed get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product liberally, as often as necessary

  • STORAGE AND HANDLING

    Storage

    Store in a cool and dry place. Close tightly after use.

  • INACTIVE INGREDIENT

    Inactive Ingredient


    Fragrance

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Health Smart Baby Powder

    NET WT. 14 OZ (397G)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART BABY 
    talc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.001 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-010-1357 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    2NDC:52862-010-14113 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    3NDC:52862-010-15397 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    4NDC:52862-010-16624 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    5NDC:52862-010-17680 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    6NDC:52862-010-18737 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 finalpart34712/19/2012
    Labeler - Home Smart Products (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-010)
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