AGROBAC FOAM WASH- benzalkonium chloride liquid
Deb USA, 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.

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Drug Facts

Active ingredient

Benzalkonium Chloride, 1.30%

Purpose

Antibacterial

Uses

For hand washing to reduce bacteria on the skin

Warnings

For external use only

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to dry hands

Add water

Lather hands for 30 seconds

Rinse and dry hands thoroughly

Inactive ingredients

Water, Cocamidopropyl Betaine, Undeceth-7, Cocamidopropylamine Oxide, Cocamide DEA, Lauramine Oxide, Tetrasodium EDTA, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

deb

AgroBac Foam Wash

40.6 fl oz

1200 mL

AGB120TF

Made in USA

Deb

Stanley, NC 28164

1-800-248-7190

www.debgroup.com

NSF

Rev. 02-10

container label

AGROBAC FOAM WASH
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-054
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.30 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-054-12	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2010	09/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/01/2010	09/01/2016

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-054)

Revised: 10/2017

Document Id: 2c8d3e3a-4f55-4197-8dc2-87471345ab90

Set id: d064734c-cf56-4209-909f-73377ff906a9

Version: 2

Effective Time: 20171012

Deb USA, Inc.