NDC Code(s) : 66949-923-01, 66949-923-24, 66949-923-16, 66949-923-85
Packager : Zep Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Zep Applaud Hand CleanerTriclosan SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66949-923
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q) 		CHLOROXYLENOL0.02 g in 10 mL
TRICLOSAN(UNII: 4NM5039Y5X)
(TRICLOSAN - UNII:4NM5039Y5X) 		TRICLOSAN0.02 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TALL OIL(UNII: 1GX6Z36A79)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
COCO DIISOPROPANOLAMIDE(UNII: S485AM948Q)
LAURIC ACID(UNII: 1160N9NU9U)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALCOHOL(UNII: 3K9958V90M)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER(UNII: 39DK5WQ2PR)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Product Characteristics
Color red, orange Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66949-923-01946 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/02/2003
2NDC:66949-923-243785 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/02/2003
3NDC:66949-923-161200 mL in 1 CASE Type 0: Not a Combination Product26/02/2003
4NDC:66949-923-85208198 mL in 1 DRUM Type 0: Not a Combination Product26/02/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/26/2003 01/02/2019

PRINCIPAL DISPLAY PANEL

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