NDC 47593-438-33
API & Excipient Details

marketed by Ecolab Inc. under NDC Code 47593-438-33

NDC Code(s) : 47593-438-33, 47593-438-11
Packager : Ecolab Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Proforce Commercial ProductsTriclosan SOLUTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:47593-438
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN(UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
POTASSIUM COCOATE(UNII: F8U72V8ZXP)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
ALCOHOL(UNII: 3K9958V90M)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
BORIC ACID(UNII: R57ZHV85D4)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE(UNII: H2KVQ74JM4)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
EDETATE SODIUM(UNII: MP1J8420LU)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
COCAMINE OXIDE(UNII: QWA2IZI6FI)
PEG-75 LANOLIN(UNII: 09179OX7TB)
METHYLPARABEN(UNII: A2I8C7HI9T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
DENATONIUM BENZOATE(UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL(UNII: MD83SFE959)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C RED NO. 4(UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47593-438-33	118 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	03/10/2008
2	NDC:47593-438-11	3780 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	03/10/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/10/2008	02/25/2019

PRINCIPAL DISPLAY PANEL