DEBMED ANTIMICROBIAL BODY WASH AND SHAMPOO- triclosan liquid

DebMed Antimicrobial Body Wash and Shampoo by

Drug Labeling and Warnings

DebMed Antimicrobial Body Wash and Shampoo by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., Deb Worldwide Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Triclosan, 0.70%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

For hand and body washing to reduce bacteria on the skin

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

Apply product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse and dry thoroughly

INACTIVE INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

DebMed Engineering Hand Hygiene Compliance

AntiMicrobial Body Wash and Shampoo

1L

33.8 fl oz

Made in USA

DMABHB1L

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	0.70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GUAR GUM (UNII: E89I1637KE)
ALLANTOIN (UNII: 344S277G0Z)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-061-27	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 11084-061-38	222 mL in 1 BOTTLE, PLASTIC

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	Business Operations
Deb USA, Inc.		607378015	manufacture

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