ALCOHOL ANTISEPTIC 80 PERCENT TOPICAL- alcohol solution 
Chattem, 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 Topical Solution

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer Non-sterile Solution

Drug Facts

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Uses

■ Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not 

   available.

■ Healthcare personnel hand rub to help reduce bacteria that potentially can cause disease.

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

PRINCIPAL DISPLAY PANEL

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-Sterile Solution
4.2 FL OZ (124 mL)

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution 4.2 FL OZ (124 mL)

ALCOHOL ANTISEPTIC 80 PERCENT TOPICAL 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4700
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:41167-4700-0124 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/202012/31/2021
Labeler - Chattem, Inc. (003336013)

Revised: 4/2022
Document Id: 5c15d81b-a347-4ecb-b57f-c3041c608a9d
Set id: f0664eeb-92e7-4709-9c7b-c9ddded0c2e5
Version: 3
Effective Time: 20220411
 
Chattem, Inc.