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.

----------

BIOMEDIK Premium Hand Sanitizer Gel [74514-3785-1] 3785 mL, Bottle+Pump

BIOMEDIK Premium Hand Sanitizer Gel (3785 ml)

BIOMEDIK PREMIUM HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74514-3785
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2649.5 mL  in 3785 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:74514-3785-13785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2020
Labeler - SISKINKOREA CO.,LTD. (695625974)
Establishment
NameAddressID/FEIBusiness Operations
SISKINKOREA CO.,LTD.695625974manufacture(74514-3785)

Revised: 5/2020
Document Id: a6fc0700-b4cc-7308-e053-2995a90a4528
Set id: a6fc0700-b4cb-7308-e053-2995a90a4528
Version: 1
Effective Time: 20200531
 
SISKINKOREA CO.,LTD.