Label: PAN AROMAS BABY- talc powder

  • 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 December 19, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Talc 100%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only.

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

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

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Pan Aromas Baby Powder

    NET WT. 14 OZ (397g)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PAN AROMAS BABY 
    talc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50346-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50346-004-1057 g in 1 BOTTLE
    2NDC:50346-004-11113 g in 1 BOTTLE
    3NDC:50346-004-12397 g in 1 BOTTLE
    4NDC:50346-004-13624 g in 1 BOTTLE
    5NDC:50346-004-14680 g in 1 BOTTLE
    6NDC:50346-004-15737 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34712/19/2012
    Labeler - Pan Aromas LLC (078451131)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(50346-004)