Label: NWC21 NATURAL WHITE CREAM- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 24, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:
    Stearalkorium Hectorite, Bentonite, Titanium Dioxide, Zinc Oxide, Talc
  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Triticum Vulgare (Wheat) Starch, Butylene Glycol, Magnesium Aluminum Silicate, PEG-32, Alcohol, Tocopheryl Acetate, Methylparaben, Cabomer, Propylparaben, Disodium EDTA, Egg Oil, Aloe Barbadensis Leaf, Algae Extract, Royal Jelly Extract, Fragrance
  • WHEN USING

    Direction of use:
    Apply evenly onto clean and moisturized skin after the cleansing and massage all over the skin with circular movement for 1-2 minutes.  Then leave them about 2-3 minutes.  Rinse with room temperature water (do not use with soap).  Use two or three times a week.
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children
  • WARNINGS

    Warning:
    1. Discontinue if the following symptom appears and consult with dermatologist for the continuous problem of use
        a) Discontinue use if redness, rash, irritation or tingling appears
        b) Discontinue if the above symptom appears by a direct sunlight on the applied part
    2. Avoid the part for a cut, eczema or dermatitis
  • STORAGE AND HANDLING

    Storage and Handling:
    - To keep the freshness, please close the lid after the use
    - Do not store this product in a place of high or low temperature
    - Do not expose it to the direct sunlight
  • PRINCIPAL DISPLAY PANEL

    BOX LABEL
  • INGREDIENTS AND APPEARANCE
    NWC21 NATURAL WHITE CREAM 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45167-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 200 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.8 g  in 200 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45167-167-51200 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/21/2010
    Labeler - Cleansia Co Ltd (687655956)
    Registrant - Cleansia Co Ltd (687655956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cleansia Co Ltd687655956manufacture
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