Bac Stop (Benzalkonium Chloride) Liquid [Wayne Concept Manufacturing Co Inc] -

BAC STOP (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]
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NDC	64495-2363-1
Set ID	7aea6ac1-9f8e-4a22-a5d2-600ca4bc03d6
Category	HUMAN OTC DRUG LABEL
Packager	Wayne Concept Manufacturing Co Inc
Generic Name
Product Class
Product Number
Application Number	PART333

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ACTIVE INGREDIENT

Active ingredient Purpose

Benzalkonium Chloride 0.13%.....................................Antimicrobial
INDICATIONS & USAGE

Uses

For hand washing to decrease bacteria on the skin

Recommended for repeated use
WARNINGS

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.
DOSAGE & ADMINISTRATION

Directions:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.
INACTIVE INGREDIENT

Inactive ingredients:

Water, butylene glycol, dihydroxypropyl PEG-5 linoleammonium chloride, dihydroxyethyl cocamine oxide, glycereth-2 cocoate, hydroxypropyl methylcellulose.
PRINCIPAL DISPLAY PANEL

Wayne

Select Line

Bac Stop

Anti-bacterial Foam Handsoap

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

INGREDIENTS AND APPEARANCE

BAC STOP
benzalkonium chloride liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.13 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Dihydroxypropyl Peg-5 Linoleammonium Chloride (UNII: 0Y0NQR2GH1)
Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)
Glycereth-2 Cocoate (UNII: JWM00VS7HC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64495-2363-1	3785 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	10/31/2009

Labeler - Wayne Concept Manufacturing Co Inc (198433179)

Name	Address	ID/FEI	Business Operations
Establishment
Wayne Concept Manufacturing Co Inc		198433179	manufacture

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Medic