ETHYL ALCOHOL 80 PERCENT- ethyl alcohol liquid 
CLUB CARIBE

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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ETHYL ALCOHOL 80 PERCENT

DOSAGE & ADMINISTRATION - ETHYL ALCOHOL 80% ANTISEPTIC

DOSAGE & ADMIN ETHYL ALCOHOL 80

WARNINGS - ETHYL ALCOHOL 80% ANTISEPTIC

WARNINGS ETHYL ALCOHOL 80

INACTIVE INGREDIENTS - ETHYL ALCOHOL 80% ANTISEPTIC

INACTIE INGREDIENTS ETHYL ALCOHOL 80

INDICATION & USAGE - ETHYL ALCOHOL 80% ANTISEPTIC

INDICATION & USAGE ETHYL ALCOHOL 80

KEEP OUT REACH CHILDREN - ETHYL ALCOHOL 80% ANTISEPTIC

KEEP OUT REACH CHILDREN ETHYL ALCOHOL 80

PURPOSE - ETHYL ALCOHOL 80% ANTISEPTIC

PURPOSE - ETHYL ALCOHOL 80

ACTIVE INGREDIENT - ETHYL ALCOHOL 80% ANTISEPTIC

ACTIVE INGREDIENT - ETHYL ALCOHOL 80

ETHYL ALCOHOL 80 PERCENT

750 mL ETHYL ALCOHOL 80%

ETHYL ALCOHOL 80 PERCENT 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74336-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74336-800-01750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - CLUB CARIBE (117033117)
Registrant - CLUB CARIBE (117033117)
Establishment
NameAddressID/FEIBusiness Operations
CLUB CARIBE117033117manufacture(74336-800)

Revised: 6/2020
Document Id: a8ed7e57-6bdf-e82a-e053-2995a90a7918
Set id: a8ed7e57-6bde-e82a-e053-2995a90a7918
Version: 1
Effective Time: 20200625
 
CLUB CARIBE