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.

----------

49283-007-01

AME HANDEE 1GAL

ETHYL ALCOHOL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-007
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
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49283-007-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/07/2020
Labeler - Chemco Corporation (032495954)
Registrant - Chemco Corporation (032495954)
Establishment
NameAddressID/FEIBusiness Operations
Chemco Corporation032495954manufacture(49283-007)

Revised: 8/2020
Document Id: ac4f3386-dfdb-1a61-e053-2a95a90a98ca
Set id: ac4f49e2-44af-e15c-e053-2995a90ac89b
Version: 4
Effective Time: 20200807
 
Chemco Corporation