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
700-02,08,18
701-02,08,18

HS ORIGINAL 2OZMain Label

ORIGINAL2OZALOE 2OZ

HS 18OZ

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
.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:49283-700-0259 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/07/2020
2NDC:49283-700-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/07/2020
3NDC:49283-700-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
ETHYL ALCOHOL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-701
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
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49283-701-0259 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/07/2020
2NDC:49283-701-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/07/2020
3NDC:49283-701-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - Chemco Corporation (032495954)
Registrant - Chemco Corporation (032495954)
Establishment
NameAddressID/FEIBusiness Operations
Chemco Corporation032495954manufacture(49283-701, 49283-700)

Revised: 7/2020
Document Id: a9dc9c78-3f20-e007-e053-2995a90afe67
Set id: 3d2fd563-2aa0-4fea-e054-00144ff88e88
Version: 3
Effective Time: 20200707
 
Chemco Corporation