ANTIBACTERIAL- benzalkonium chloride soap

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Rubbermaid Commercial Products LLC, Abaco Partners LLC DBA Surefil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

0.13% Benzalkonium Chloride

Purpose

Antibacterial Hand Wash

Use

For hand washing to decrease bacteria on skin. Repeat as needed.

Warnings

• For external use only.

• When using this product avoid contact with eyes. In case of eye contact, flush with water.

• Stop use and ask a doctor, if irritation or redness persist.

• Do not ingest.

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

Directions

Wet hands, place hands under the dispenser to allow 0.8ml of hand wash to squirt into hands, wash thoroughly for at least 30 seconds, rinse hands thoroughly with potable water after washing.

Inactive Ingredients

Water, Cetrimonium Chloride, Glycerin, Sodium Chloride, Lauramidopropylamine Oxide, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazilinone, Methylisothiazilinone.

Questions?

1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

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Distributed by Rubbermaid Commercial Products LLC
3124 Valley Avenue, Winchester, VA U.S.A. 22601-2694

PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label

Rubbermaid®
Commercial Products

TECHNICAL CONCEPTS

Antibacterial Lotion Soap

To be used with OneShot® liquid dispensers
800mL
(27 FL. OZ.)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65321-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	13 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetrimonium Chloride (UNII: UC9PE95IBP)
Glycerin (UNII: PDC6A3C0OX)
Sodium Chloride (UNII: 451W47IQ8X)
Lauramidopropylamine Oxide (UNII: I6KX160QTV)
Coco Monoethanolamide (UNII: C80684146D)
PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Sodium (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65321-031-01	800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/24/2017
2	NDC: 65321-031-02	1600 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	07/24/2017

Labeler - Rubbermaid Commercial Products LLC (049924368)

Establishment
Name	Address	ID/FEI	Business Operations
Abaco Partners LLC DBA Surefil		964809417	MANUFACTURE(65321-031)