BIOMEDIK PREMIUM HAND SANITIZER GEL- alcohol gel 
SISKINKOREA 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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BIOMEDIK Premium Hand Sanitizer Gel [74514-5570-1] 500 mL, Bottle+Pump

BIOMEDIK Premium HAND SANITIZER Gel

BIOMEDIK PREMIUM HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74514-5570
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
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PANTHENOL (UNII: WV9CM0O67Z)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74514-5570-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - SISKINKOREA CO.,LTD. (695625974)
Establishment
NameAddressID/FEIBusiness Operations
SISKINKOREA CO.,LTD.695625974manufacture(74514-5570)

Revised: 5/2020
Document Id: a69b01f5-dd67-733f-e053-2995a90a3047
Set id: a698b5a9-acd6-161b-e053-2a95a90a7e91
Version: 2
Effective Time: 20200527
 
SISKINKOREA CO.,LTD.