NWC21 NATURAL WHITE CREAM - titanium dioxide, 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 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

Revised: 1/2010
Document Id: 2fc4d5d7-bf45-4b1d-893b-12d05f919527
Set id: dd15c7ac-091f-4a99-a0e6-473184148b61
Version: 1
Effective Time: 20100124
 
Cleansia Co Ltd