Label: SPAI-SONS FINE TALCUM- 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 5, 2012

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  • ACTIVE INGREDIENT

    The active ingredient are Talc and Zinc Oxide

  • PURPOSE

    This product is used to keep cool moist areas of the body as the feet and armpits, and retain moisture from them.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children this product

  • INDICATIONS & USAGE

    Use the product in the feet after the shower

  • WARNINGS

    Do not take this product is only for topical application. If swallowed consult your doctor.

  • DOSAGE & ADMINISTRATION

    This product is for topical application, apply a moderate amount desired area.

  • INACTIVE INGREDIENT

    Inactive ingredients not produce irritation or healt effects.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL IMAGE OF THE LABELIMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SPAI-SONS  FINE TALCUM
    talc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC81 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Product Characteristics
    Colorwhite (WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-018-01150 g in 1 BOTTLE
    2NDC:66854-018-02250 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/30/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, manufacture, label, pack
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