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.

----------

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:64495-2362
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dihydroxypropyl Peg-5 Linoleammonium Chloride (UNII: 0Y0NQR2GH1)  
Glycereth-2 Cocoate (UNII: JWM00VS7HC)  
Behentrimonium Chloride (UNII: X7GNG3S47T)  
Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64495-2362-8532 mL in 1 BOTTLE, PUMP
2NDC:64495-2362-13785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33303/31/2008
Labeler - Wayne Concept Manufacturing Co Inc (198433179)
Establishment
NameAddressID/FEIBusiness Operations
Wayne Concept Manufacturing Co Inc198433179manufacture

Revised: 6/2010
Document Id: 5f1399de-c671-42ae-be9d-29b06515c2f2
Set id: 5fce3a50-3195-4891-a6ac-7b5aef4e80ea
Version: 1
Effective Time: 20100602
 
Wayne Concept Manufacturing Co Inc