Label: NATURES CHOICE BABY- talc powder

  • 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 June 13, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient

    Talc 99%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    It helps to absorb excess moisture, keeps the baby’s skin dry and soft for ultimate comfort.

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
    • For external use only.
    • Avoid contact with eyes, discontinue use if irritation persists.
    • Avoid ingestion or accidental inhalation by baby. Seek professional assistance if needed.
  • DOSAGE & ADMINISTRATION

    Directions

    After changing diapers and after every bath dry baby’s skin thoroughly and apply liberally as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    Package/Label Principal Display Panel

    Natures Choice Baby Powder

    Velvety Soft

    NET WT 22 OZ (624 g)

    LABEL

  • INGREDIENTS AND APPEARANCE
    NATURES CHOICE BABY 
    talc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC99 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-112-0550 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    2NDC:43749-112-06100 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    3NDC:43749-112-07113 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    4NDC:43749-112-09116 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    5NDC:43749-112-10368 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    6NDC:43749-112-11396 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    7NDC:43749-112-14424 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    8NDC:43749-112-15624 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/07/2016
    Labeler - Unipack, Inc. (009248480)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(43749-112)
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