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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Talc 100%

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  • PURPOSE

    Purpose

    Skin Protectant

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  • 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.

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  • WARNINGS

    Warning

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply product liberally, as often as necessary

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  • STORAGE AND HANDLING

    Storage

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

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  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

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  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Health Smart Baby Powder

    NET WT. 14 OZ (397G)

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  • INGREDIENTS AND APPEARANCE
    HEALTH SMART BABY 
    talc powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52862-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TALC (TALC) TALC 1 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52862-010-13 57 g in 1 BOTTLE
    2 NDC:52862-010-14 113 g in 1 BOTTLE
    3 NDC:52862-010-15 397 g in 1 BOTTLE
    4 NDC:52862-010-16 624 g in 1 BOTTLE
    5 NDC:52862-010-17 680 g in 1 BOTTLE
    6 NDC:52862-010-18 737 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 12/19/2012
    Labeler - Home Smart Products (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52862-010)
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