DRUG FACTS

SOORYEHAN PURE WHITENING SPOT TREATMENT - polydatin cream
LG Household and Healthcare, Inc.

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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DRUG FACTS

POLYDATIN 0.21mL/100mL

For external use only

Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

Keep out of eyes. Rinse with water to remove.

Stop use if a rash or irritation develops and lasts.

jingo

SOORYEHAN PURE WHITENING SPOT TREATMENT
polydatin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53208-444
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYDATIN (UNII: XM261C37CQ) (POLYDATIN - UNII:XM261C37CQ)	POLYDATIN	0.21 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PANTHENOL (UNII: WV9CM0O67Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description
Packaging
1	NDC:53208-444-02	1 in 1 BOX
1	NDC:53208-444-01	25 mL in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358	04/26/2010

Labeler - LG Household and Healthcare, Inc. (688276187)

Registrant - LG Household and Healthcare, Inc. (688276187)

Name	Address	ID/FEI	Business Operations
Establishment
LG Household and Healthcare, Inc.		688276187	manufacture