DEB 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, Lauramine Oxide, Tetrasodium EDTA, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone

AGB1L-DCN9245 AgroBac.jpg

deb stoko

AgroBac Foam Wash

Perfume Free and Dye Free Antibacterial Foam Hand Soap

Antibacterial

deb

Deb USA, Inc. Charlotte, NC 28217

1-800-248-7190 www.debgroup.com

AGB1L

1 L

(33.8 fl oz)

DCN9245/0916

AGB1L-DCN9245 AgroBac.jpg

DEB AGROBAC FOAM WASH
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-254
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.13 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
UNDECETH-7 (UNII: R6B5PCO2JN)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
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:11084-254-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2013	12/31/2021
2	NDC:11084-254-20	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2013	12/31/2021
3	NDC:11084-254-12	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2013	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/20/2013	12/31/2021

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-254)

Revised: 12/2018

Document Id: 004fff0b-7822-4fc2-8058-65f959b46571

Set id: a72ae9f5-7108-478e-ba5b-77c88c857541

Version: 3

Effective Time: 20181218

Deb USA, Inc.