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

BAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]
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NDC	64495-2365-1, 64495-2365-8
Set ID	eb0360db-dd0d-4ba2-aae4-0ef815f7cbb5
Category	HUMAN OTC DRUG LABEL
Packager	Wayne Concept Manufacturing Co Inc
Generic Name
Product Class
Product Number
Application Number	PART333A

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ACTIVE INGREDIENT

Active ingredients

Benzalkonium Chloride 0.1%
PURPOSE

Purpose

Antimicrobial
INDICATIONS & USAGE

Uses:

For hand sanitizing 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.

Rub hands together briskly until dry.
INACTIVE INGREDIENT

Inactive ingredients:

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance
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

INGREDIENTS AND APPEARANCE

BAC OFF
benzalkonium chloride liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64495-2365-8	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/21/2018
2	NDC:64495-2365-1	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2012

Labeler - Wayne Concept Manufacturing Co Inc (198433179)

Name	Address	ID/FEI	Business Operations
Establishment
Wayne Concept Manufacturing Co Inc		198433179	manufacture(64495-2365)

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