WHITE ORGANIA FRESH PURE HAND SANITIZER- ethanol gel 
WHITE COSPHARM 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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WHITE ORGANIA FRESH PURE HAND SANITIZER 500 ml

500

WHITE ORGANIA FRESH PURE HAND SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75312-0500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GRAPEFRUIT (UNII: O82C39RR8C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75312-0500-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2020
Labeler - WHITE COSPHARM CO.,LTD. (688442259)
Establishment
NameAddressID/FEIBusiness Operations
WHITE COSPHARM CO.,LTD.688442259manufacture(75312-0500)

Revised: 4/2020
Document Id: a3b7ff9d-733d-187e-e053-2995a90aefa6
Set id: a3b7ff9d-733c-187e-e053-2995a90aefa6
Version: 1
Effective Time: 20200417
 
WHITE COSPHARM CO.,LTD.