ALCOHOL - HAND SANITIZER- alcohol solution 
AbbVie 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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Drug Facts

Active Ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

Hand Sanitizer to help reduce 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 between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Questions? Tel: 1-800-633-9110

Manufactured by: AbbVie Inc. North Chicago, IL 60064

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer

Non-sterile Solution

300 mL

Hand Sanitizer Label 300mL_V1.1

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer

Non-sterile Solution

1000 mL

Hand Sanitizer Label 1000mL_V1.1

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer

Non-sterile Solution

2000 mL

Hand Sanitizer Label 2000mL_V1.1

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer

Non-sterile Solution

20 L

Hand Sanitizer Label 20L_V1.1

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer

Non-sterile Solution

200 L

Hand Sanitizer Label 200L_V1.1

ALCOHOL - HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0074-9857
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:0074-9857-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
2NDC:0074-9857-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
3NDC:0074-9857-152000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
4NDC:0074-9857-2020000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
5NDC:0074-9857-25200000 mL in 1 DRUM; Type 0: Not a Combination Product03/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/25/202012/31/2021
Labeler - AbbVie Inc. (078458370)

Revised: 4/2020
Document Id: b1ad374c-4719-4de4-bdde-4eb5a9fd0164
Set id: 69193505-73f3-94c0-64f0-572b78e68fc8
Version: 12
Effective Time: 20200414
 
AbbVie Inc.