Drug Facts

DEBMED ANTIMICROBIAL BODY WASH AND SHAMPOO - 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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Active ingredient

Triclosan, 0.70%

Purpose

Antimicrobial

Uses

For hand and body 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 product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse and dry thoroughly

Inactive ingredients

Water, Disodium Laureth Sulfosuccinate, Sodium Laureth Sulfate, TEA-Dodecylbenzene Sulfonate, Citric Acid, Phenoxyethanol, Hyroxypropyl Guar Hydroxypropyltrimonium Chloride, Aloe Barbadensis Leaf Juice, Sodium Benzoate, Allantoin, Sodium Chloride, Tetrasodium EDTA, Potassium Sorbate, Fragrance, Yellow 5 (CI19140), Red 40 (CI 16035), Blue 1 (CI 42090).

DebMed Engineering Hand Hygiene Compliance

AntiMicrobial Body Wash and Shampoo

33.8 fl oz

Made in USA

DMABHB1L

container label

DEBMED ANTIMICROBIAL BODY WASH AND SHAMPOO
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-061
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (Triclosan)	Triclosan	0.70 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
DISODIUM LAURETH SULFOSUCCINATE
TEA-DODECYLBENZENESULFONATE
SODIUM LAURETH SULFATE
ANHYDROUS CITRIC ACID
PHENOXYETHANOL
SODIUM CHLORIDE
EDETATE SODIUM
ALOE VERA LEAF
GUAR GUM
ALLANTOIN
FD&C RED NO. 40
FD&C YELLOW NO. 5
SODIUM BENZOATE
POTASSIUM SORBATE
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:11084-061-27	1000 mL in 1 BOTTLE, PLASTIC	None
2	NDC:11084-061-38	222 mL in 1 BOTTLE, PLASTIC	None

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

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Operations
Deb USA, Inc.		607378015	manufacture

Establishment
Name	Address	ID/FEI	Operations
Deb Worldwide Healthcare Inc.		205662831	manufacture

Revised: 07/2011 Deb USA, Inc.