ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION - arbutin lotion 
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

ARBUTIN 2.10g/100g

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.

BRIGHTENINGEMULSION
ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION 
arbutin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-385
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF) ARBUTIN2.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
CAPRIC ACID (UNII: 4G9EDB6V73)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
2-ETHYLHEXANOIC ACID (UNII: 01MU2J7VVZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BETAINE (UNII: 3SCV180C9W)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CARBOMER 934 (UNII: Z135WT9208)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-385-021 in 1 BOX
1NDC:53208-385-01120 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35803/29/2010
Labeler - LG Household and Healthcare, Inc. (688276187)
Registrant - LG Household and Healthcare, Inc. (688276187)
Establishment
NameAddressID/FEIBusiness Operations
LG Household and Healthcare, Inc.688276187manufacture

Revised: 3/2010
Document Id: 33a6f73b-4cc8-407a-8cf1-f07403a3284a
Set id: 7ced5492-9ef6-4c0b-b040-d5dae08e4501
Version: 1
Effective Time: 20100329
 
LG Household and Healthcare, Inc.