ALCOHOL ANTISEPTIC 80%- alcohol solution 
Alcon 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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HAND SANITIZER

Drug Facts

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.

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

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

  • 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  

Consumer Label
Consumer Label

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   

Healthcare Professional Label
ALCOHOL ANTISEPTIC 80% 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-8000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-8000-0310000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/202007/31/2021
2NDC:0065-8000-0410000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/202007/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/202007/31/2021
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-8000)

Revised: 7/2021
Document Id: 89d319a3-be23-4162-842e-01c794f3ae2a
Set id: 1f18be11-f529-44d4-814e-6dc4b40ac15e
Version: 2
Effective Time: 20210721
 
Alcon Laboratories, Inc.