Label: PAN AROMAS BABY- talc powder 

  • Label RSS
  • NDC Code(s): 50346-004-10, 50346-004-11, 50346-004-12, 50346-004-13, view more
    50346-004-14, 50346-004-15
  • Packager: Pan Aromas LLC
  • 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

    To help absorb excess moisture and keep your baby's skin dry and soft. Close
  • WARNINGS

    Warnings

    For external use only.

    Keep away from baby's nose and mouth. Close lid after use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

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

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  • DOSAGE & ADMINISTRATION

    Directions

    After changing nappies and after every bath, dry baby's skin thoroughly and apply liberally as needed

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  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

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  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Pan Aromas Baby Powder

    NET WT. 14 OZ (397g)

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  • INGREDIENTS AND APPEARANCE
    PAN AROMAS BABY 
    talc powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50346-004
    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:50346-004-10 57 g in 1 BOTTLE
    2 NDC:50346-004-11 113 g in 1 BOTTLE
    3 NDC:50346-004-12 397 g in 1 BOTTLE
    4 NDC:50346-004-13 624 g in 1 BOTTLE
    5 NDC:50346-004-14 680 g in 1 BOTTLE
    6 NDC:50346-004-15 737 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 - Pan Aromas LLC (078451131)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(50346-004)
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