ICI PLEASANTLY PERFUMED ANTIBACTERIAL FOAM HANDWASH- 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, 0.30%

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 foaming cleanser to dry hands

rub hands together to spread lather

wash for 15-20 seconds

rinse & dry hands thoroughly

Inactive ingredients

AQUA (WATER), SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, PEG-7 GLYCERYL COCOATE, GLYCERIN, COCAMIDOPROPYL BETAINE,
2-BROMO-2-NITROPROPANE-1,3-DIOL, PARFUM (FRAGRANCE), CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, GREEN 5 (CI 61570), YELLOW 5 (CI 19140)

ICI

Pleasantly Perfumed Antibacterial Foam Handwash

Espuma antibacteriana y perfumada para higiene de manos

Distributed in the USA by:

Illinois Correctional Industries

Springfield, IL 62794

1-800-634-0213

Made in USA

Stock #

ICIANT1L/0715

1 L

(33.8 fl oz)

ICIANT1L-AntiBac FOAM-V3

ICI PLEASANTLY PERFUMED ANTIBACTERIAL FOAM HANDWASH
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.003 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BRONOPOL (UNII: 6PU1E16C9W)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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:11084-103-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/27/2015	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/27/2015	08/01/2020

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-103)

Revised: 12/2017

Document Id: b62015e3-0059-4e51-9057-bcca8835259d

Set id: 279433de-8e44-407c-9b57-1cd7dcfe0ee5

Version: 2

Effective Time: 20171221

Deb USA, Inc.