ANTIBAC FH FOAM CUCUMBER ALOE WITH MICROHYDRATION- triclosan, 0.7% solution
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.

----------

Drug Facts

Active ingredient

TRICLOSAN, 0.70%

Purpose

Antimicrobial

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, PARFUM (FRAGRANCE), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, GREEN 5 (CI 61570), YELLOW 5 (CI 19140)

Other information:

For professional use in healthcare settings.

AMCA1L-DCN9256 Antimicrobial Foam HW-V2.jpg

deb stoko

AntiBAC FH FOAM

Cucumber Aloe with Microhydration

Deb USA, Inc. Charlotte, NC 28217

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

Made in the USA

AMCA1L 1 L

(33.8 fl oz)

DCN9256/1116

AMCA1L-DCN9256 Antimicrobial Foam HW-V2.jpg

ANTIBAC FH FOAM CUCUMBER ALOE WITH MICROHYDRATION
triclosan, 0.7% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-004
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)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-004-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2017	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/05/2017	12/31/2021

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-004)

Revised: 12/2018

Document Id: fb9f10c1-3347-4cba-81e7-b59bfde05eec

Set id: 200d3302-dfbf-4da1-aac7-36843959f6b3

Version: 3

Effective Time: 20181218

Deb USA, Inc.