PAN AROMAS BABY (TALC) POWDER [PAN AROMAS LLC]

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PAN AROMAS BABY (TALC) POWDER [PAN AROMAS LLC]
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NDC 50346-004-10, 50346-004-11, 50346-004-12, 50346-004-13, 50346-004-14, 50346-004-15
Set ID 9b80ce99-f192-4b00-bbb2-1dfac539b41f
Category HUMAN OTC DRUG LABEL
Packager Pan Aromas LLC
Generic Name
Product Class
Product Number
Application Number PART347
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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)
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