NDC Code(s) : 64495-2362-8, 64495-2362-1
Packager : Wayne Concept Manufacturing Co Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

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(UNII: F5UM2KM3W7)
(Benzalkonium - UNII:7N6JUD5X6Y) 		Benzalkonium Chloride0.1 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1NDC:64495-2362-8532 mL in 1 BOTTLE, PUMP
2NDC:64495-2362-13785 mL in 1 BOTTLE, PLASTIC
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 Business Operations
Wayne Concept Manufacturing Co Inc 198433179 manufacture

PRINCIPAL DISPLAY PANEL

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

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