BAC-OFF E3- alcohol solution 
All American Chemical Company 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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Active Ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use

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

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

Other information

Store between 15-300C (59-860F)
Avoid freezing and excessive heat above 400C (1040F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Label

BAC-OFF E3 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28741-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 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:28741-001-014 in 1 CASE06/03/2020
13785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/03/2020
Labeler - All American Chemical Company Inc. (099215790)
Establishment
NameAddressID/FEIBusiness Operations
All American Chemical Company Inc.099215790manufacture(28741-001)

Revised: 6/2020
Document Id: a47fa7d3-9b94-48bd-9ede-d8473893e436
Set id: bc3f705e-4d5c-4b18-bed0-12fea06fed59
Version: 1
Effective Time: 20200603
 
All American Chemical Company Inc.