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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Drug Facts

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

1L

33.8 fl oz

Made in USA

DMABHB1L

container label

DEBMED ANTIMICROBIAL BODY WASH AND SHAMPOO 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-061-271000 mL in 1 BOTTLE, PLASTIC
2NDC:11084-061-38222 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2011
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture
Establishment
NameAddressID/FEIBusiness Operations
Deb Worldwide Healthcare Inc.205662831manufacture

Revised: 7/2011
Document Id: 35a1c36f-2247-40e0-9c4c-221410452b3f
Set id: 5430f280-c005-46a8-b90d-bd4673d6d04f
Version: 3
Effective Time: 20110719
 
Deb USA, Inc.