ICI FOOD HANDLER FOAM WASH- triclosan soap
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

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, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

ICIAFH1L-Antibac Foam for Food Handlers-V3

ICI Food Handler Foam Wash Espuma antibacteriana para los manipuladores de alimentos Distributed in the USA by: Illinois Correctional Industries Springfield, IL 62794 1-800-634-0213 Made in USA Stock #: ICIAFH1L/0715 1 L (33.8 fl oz)

ICI FOOD HANDLER FOAM WASH
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-663
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.007 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:11084-663-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/27/2015	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/27/2015	12/31/2021

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-663)

Revised: 12/2018

Document Id: 66a32659-3eac-4ed6-8248-5020eeabbd05

Set id: 8ceab8a7-20ea-4fda-9823-5116fee6e746

Version: 2

Effective Time: 20181219

Deb USA, Inc.