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Name:Nwc21 Natural White Cream
Manufacturer:Cleansia Co Ltd
Category:Over-the-counter (OTC) Marketed Drugs


NWC21 NATURAL WHITE CREAM  - titanium dioxide and zinc oxide cream 
Cleansia Co Ltd

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.

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

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

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 this and all drugs out of reach of children

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:
- 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

BOX LABEL

NWC21 NATURAL WHITE CREAM 
titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45167-167
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2 g  in 200 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.8 g  in 200 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45167-167-51 200 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/21/2010

Labeler - Cleansia Co Ltd (687655956)
Registrant - Cleansia Co Ltd (687655956)
Establishment
Name Address ID/FEI Operations
Cleansia Co Ltd 687655956 manufacture

Revised: 01/2010 Cleansia Co Ltd



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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