ANTIBAC FH PURE FOAM- triclosan liquid 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.

----------

AntiBAC FH Pure FOAM

Active ingredient

TRICLOSAN, 0.70%

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 foaming cleanser to dry hands

rub hands together to spread lather

wash for 15-20 seconds

rinse & dry hands thoroughly

Inactive ingredients

AQUA (WATER), PROPYL ALCOHOL, BUTYLENE GLYCOL, SODIUM LAURETH SULFATE, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, ETHYLHEXYLGLYCERIN, BENZYL ALCOHOL, PHENOXYETHANOL, POLYGLYCERIN-6, CITRIC ACID, DMDM HYDANTOIN, DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE, TETRASODIUM EDTA, ALLANTOIN, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

Other information:

For professional use in food handling and food processing.

AFH1L-DCN9105 AntiBac PURE FH Foam V10.jpg

deb stoko

AntiBAC FH Pure FOAM

deb

Deb USA, Inc. Charlotte, NC 28217

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

Made in USA

AFH 1L

1L (33.8 fl oz)

DCN9105/0916

AFH1L-DCN9105 AntiBac PURE FH Foam V10.jpg

ANTIBAC FH PURE FOAM
triclosan liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-662
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.70 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYL ALCOHOL (UNII: 96F264O9SV)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERIN-6 (UNII: M51422LRAM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
EDETATE SODIUM (UNII: MP1J8420LU)
ALLANTOIN (UNII: 344S277G0Z)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-662-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2014
2	NDC:11084-662-20	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2014	12/31/2021
3	NDC:11084-662-12	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2015	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/13/2014	12/31/2021

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-662)

Revised: 12/2018

Document Id: c25a7909-a8b7-46a6-8460-8776a328d15b

Set id: 0e6e9bc8-b055-4283-b864-527b97180a02

Version: 5

Effective Time: 20181218

Deb USA, Inc.