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Name:Bac Off
Manufacturer:Wayne Concept Manufacturing Co Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BAC OFF   - benzalkonium chloride liquid 
Wayne Concept Manufacturing Co 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 ingredients                                                          Purpose

Benzalkonium Chloride 0.1%..........................................Antimicrobial

Uses:

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Pump a small amount of foam into palms of hand.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.


Inactive ingredients:

Water (aqua), dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2-cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide.

Wayne

Select Line

BAC OFF

Instant Foam Hand Sanitizer

Manufactured by:

Wayne Concept Manufacturing Co., Inc.

Fort Wayne, IN 46825        260-482-8615

Net Contents: 1 U.S. Gallon (3.785 L)

Serving the maintenance community since 1933

container label




BAC OFF  
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64495-2362
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 0.1 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Dihydroxypropyl Peg-5 Linoleammonium Chloride  
Glycereth-2 Cocoate  
Behentrimonium Chloride  
Dihydroxyethyl Cocamine Oxide  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64495-2362-8 532 mL in 1 BOTTLE, PUMP None
2 NDC:64495-2362-1 3785 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 03/31/2008

Labeler - Wayne Concept Manufacturing Co Inc (198433179)
Establishment
Name Address ID/FEI Operations
Wayne Concept Manufacturing Co Inc 198433179 manufacture

Revised: 06/2010 Wayne Concept Manufacturing Co Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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