DEB MED ANTIMICROBIAL FOAMING HAND WASH FRESH GRAPEFRUIT- triclosan 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

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 hands

Rub hands together to spread lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

Inactive ingredients

Water, Propyl Alcohol, Butylene Glycol, Sodium Laureth Sulfate, Disodium Laureth Sulfosuccinate, Cocamidopropyl Betaine, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Polyglycerin-6, Citric Acid, DMDM Hydantoin, Cocamidopropyl PG-Dimonium Chloride Phosphate, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Tetrasodium EDTA, Allantoin, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Seed Extract, Blue 1 (CI 42090), Red 33 (CI 17200).

deb med Engineering Hand Hygiene Compliance

AntiMicrobial Foaming Hand Wash with Microhydration

Meets Protocol For Healthcare Personnel Handwash

33.8 fl oz

Made in USA

www.debgroup.com

DMAMFG1L

Fresh Grapefruit Fragrance

Rev. 01-11

container label

DEB MED ANTIMICROBIAL FOAMING HAND WASH FRESH GRAPEFRUIT
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-062
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	.70 mL in 100 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)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYGLYCERIN-6 (UNII: M51422LRAM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
EDETATE SODIUM (UNII: MP1J8420LU)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
ALLANTOIN (UNII: 344S277G0Z)
CITRUS MAXIMA SEED (UNII: 083X55C543)
ORANGE PEEL (UNII: TI9T76XD44)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-062-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/10/2011	07/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/10/2011	07/01/2017

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-062)

Name	Address	ID/FEI	Business Operations
Establishment
Deb Worldwide Healthcare Inc.		205662831	manufacture(11084-062)

Revised: 11/2017

Document Id: 72466d71-e01b-4ce5-afe1-1841704bbe55

Set id: 87ebb536-fa05-4ee7-8c0f-0ba9a3a37d06

Version: 5

Effective Time: 20171107

Deb USA, Inc.