NDC Code(s) : 45802-961-26
Packager : Padagis Israel Pharmaceuticals Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

clobetasol propionateClobetasol Propionate SHAMPOO
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-961
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE(UNII: 779619577M)
(CLOBETASOL - UNII:ADN79D536H) 		CLOBETASOL PROPIONATE0.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
COCO-BETAINE(UNII: 03DH2IZ3FY)
POLYQUATERNIUM-10 (400 MPA.S AT 2%)(UNII: HB1401PQFS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-961-26118 mL in 1 BOTTLE Type 0: Not a Combination Product08/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090974 08/10/2012

LABELER - Padagis Israel Pharmaceuticals Ltd(600093611)

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 45802-961-26

Clobetasol Propionate Shampoo, 0.05%

For External Use Only

Do Not Use in Eyes

4 FL OZ (118 mL)

label

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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