removal of product, product discontinuation

ETHYL ALCOHOL 75% by

Drug Labeling and Warnings

ETHYL ALCOHOL 75% by is a Otc medication manufactured, distributed, or labeled by ALFA VITAMINS LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ETHYL ALCOHOL 75%- rubbing alcohol liquid 
ALFA VITAMINS LABORATORIES INC

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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removal of product, product discontinuation.

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)
Ehtyl Alcohol 75% v/v

Purpose

First aid antiseptic

Use

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

For external use only. Fammable, keep away from spark, heat and flame

Do not use

• When using this product do not get into eyes, do not apply over large areas of the body, do not use longer than 1 week.
• 
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Package Label - Principal Display Panel

ETHYL ALCOHOL 75% 
rubbing alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13298-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL ISOBUTYRATE (UNII: EM286QL922)	1.5 mL  in 100 mL
ACETONE (UNII: 1364PS73AF)	8 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	19 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13298-253-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/20/2020	10/30/2020

Labeler - ALFA VITAMINS LABORATORIES INC (120728212)

Registrant - ALFA VITAMINS LABORATORIES INC (120728212)

Establishment
Name	Address	ID/FEI	Business Operations
ALFA VITAMINS LABORATORIES INC		120728212	manufacture(13298-253) , label(13298-253) , pack(13298-253)

Revised: 8/2021

Document Id: ca516dc6-65ac-81d0-e053-2a95a90a660c

34390-5

Set id: b21e22a5-77ac-7569-e053-2a95a90acf03

Version: 2

Effective Time: 20210824