NDC Code(s) : 0168-0263-15, 0168-0263-45, 0168-0263-60
Packager : E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alclometasone Dipropionatealclometasone dipropionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0263
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCLOMETASONE DIPROPIONATE(UNII: S56PQL4N1V)
(ALCLOMETASONE - UNII:136H45TB7B) 		ALCLOMETASONE DIPROPIONATE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETETH-20(UNII: I835H2IHHX)
POLYETHYLENE GLYCOL 4500(UNII: TVH7653921)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CHLOROCRESOL(UNII: 36W53O7109)
PETROLATUM(UNII: 4T6H12BN9U)
WATER(UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(UNII: 3980JIH2SW)
PHOSPHORIC ACID(UNII: E4GA8884NN)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0168-0263-1515 g in 1 TUBE Type 0: Not a Combination Product07/12/2005
2NDC:0168-0263-4545 g in 1 TUBE Type 0: Not a Combination Product07/12/2005
3NDC:0168-0263-6060 g in 1 TUBE Type 0: Not a Combination Product07/12/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076973 07/12/2005

LABELER - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.(043838424)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

NDC 0168-0263-15

FOUGERA ®

ALCLOMETASONE
DIPROPIONATE CREAM
USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
WARNING: Keep out of reach of children.

NET WT 15 grams

15gramtube

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

NDC 0168-0263-15

FOUGERA ®

ALCLOMETASONE DIPROPIONATE
CREAM USP, 0.05%

Rx only

NOT FOR OPHTHALMIC USE
FOR DERMATOLOGIC USE ONLY
WARNING: Keep out of reach
of children.

NET WT 15 grams

15gramcarton.jpg