ALCOHOL ANTISEPTIC 80%- alcohol solution

Alcohol Antiseptic 80% by

Drug Labeling and Warnings

Alcohol Antiseptic 80% by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 80%

Purpose

Hand sanitizer to help decrease bacteria that potentially can cause disease. For use when soap and water are not available.

INDICATIONS & USAGE

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

ASK DOCTOR

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

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.

Other information

• Store below 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)
  

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Questions?

In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.com

PACKAGE LABEL

NOT FOR SALE
NDC: NDC: 0065-8000-04

Alcohol Antiseptic 80%
Topical Solution

Antiseptic Hand Rub 

Non-sterile Solution

10,000 mL Fill Volume

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134

LOT:                 EXP: 

PN: 1-333333333  

NOT FOR SALE
NDC: 0065-8000-03

Alcohol Antiseptic 80%
Topical Solution

Antiseptic Hand Rub 

Non-sterile Solution

10,000 mL Fill Volume

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134

LOT:                 EXP: 

PN: 1-444444444   

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 80% 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-8000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Hydrogen Peroxide (UNII: BBX060AN9V)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-8000-03	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020
2	NDC: 0065-8000-04	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-8000)