NDC Code(s) : 65585-495-01
Packager : Whisk Products, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alpha E-2Benzalkonium Chloride SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65585-495
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE(UNII: M4SL82J7HK)
PEG-6 COCAMIDE(UNII: YZ6NLA4O1E)
HYPROMELLOSES(UNII: 3NXW29V3WO)
QUATERNIUM-15(UNII: E40U03LEM0)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65585-495-013785 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/01/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/21/2008

PRINCIPAL DISPLAY PANEL

Label for ShortNeck Bottle - 1 gallon