ETHANOL- ethanol liquid 
Golden Leaf Energy

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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Active ingredient - Ethanol

Ethanol

DosageDrug Facts/Warnings

IndicationsDrug Facts - Indications and usage

Drug Facts - Purpose Purpose

Keep out of reachDrug Facts - Keep out of reach of children

Inactive IngredientsDrug Facts - Inactive Ingredients

Drug Facts - Dosage Dosage

96% Ethanol - 1000L

1000 Ethanol 1000L- Ethanol

ETHANOL 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79137-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 L  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79137-001-011 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product06/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2020
Labeler - Golden Leaf Energy (117535023)
Establishment
NameAddressID/FEIBusiness Operations
Golden Leaf Energy117535023manufacture(79137-001)

Revised: 6/2020
Document Id: a9048423-5684-727d-e053-2a95a90a38cd
Set id: a902a3b0-a538-8e6b-e053-2a95a90a7d5d
Version: 1
Effective Time: 20200619
 
Golden Leaf Energy