Label: ETHANOL liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 79137-001-01 - Packager: Golden Leaf Energy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 19, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient - Ethanol
- WARNINGS
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- 96% Ethanol - 1000L
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INGREDIENTS AND APPEARANCE
ETHANOL
ethanol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79137-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 1 L in 1 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79137-001-01 1 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 06/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/22/2020 Labeler - Golden Leaf Energy (117535023) Establishment Name Address ID/FEI Business Operations Golden Leaf Energy 117535023 manufacture(79137-001)
Drug Facts/Warnings
Drug Facts - Indications and usage
Drug Facts - Keep out of reach of children
Drug Facts - Inactive Ingredients
- Ethanol