ETHYL ALCOHOL- ethyl alcohol gel 
Chemco Corporation

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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49283-700-01

KLEANR HS 1GAL

ETHYL ALCOHOL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.05 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 1 mL  in 100 mL
BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.45 mL  in 100 mL
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.01 mL  in 100 mL
LINALOOL, (+)- (UNII: F4VNO44C09) 0.01 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.35 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.1 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49283-700-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/2020
Labeler - Chemco Corporation (032495954)
Registrant - Chemco Corporation (032495954)
Establishment
NameAddressID/FEIBusiness Operations
Chemco Corporation032495954manufacture(49283-700)

Revised: 8/2020
Document Id: abfa8419-2af3-a05a-e053-2a95a90a6cc9
Set id: a757c10e-a1c8-15a8-e053-2a95a90adb80
Version: 3
Effective Time: 20200803
 
Chemco Corporation