ALCOHOL ANTISEPTIC 80- alcohol liquid
Resource One 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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Alcohol Antiseptic 80% Topical Solution

Drug Facts

Active Ingredient:

Alcohol 80% v/v

Purpose:

Antiseptic

Use(s):

Hand sanitizer to help reduce the bacteria that potentially will cause disease

Warnings:

For External Use Only
Flammable keep away from children

When using this product:

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop and ask a doctor if:

If irration 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:

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing

Inactive Ingredients:

Glycerin, Hydrogen peroxide, purified water USP

Packaeg Labeling:

Bottle

ALCOHOL ANTISEPTIC 80
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77188-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77188-000-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/11/2020

Labeler - Resource One Inc (081366510)