NDC Code(s) : 0462-0263-15, 0462-0263-60, 0462-0264-15, 0462-0264-60
Packager : Pharmaderm, A division of Nycomed US Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aclovatealclometasone dipropionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0462-0263
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alclometasone dipropionate(UNII: S56PQL4N1V)
(alclometasone dipropionate - UNII:S56PQL4N1V) 		alclometasone dipropionate0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Ceteth-20(UNII: I835H2IHHX)
Polyoxyl 100 Stearate(UNII: YD01N1999R)
Glyceryl Monostearate(UNII: 230OU9XXE4)
Chlorocresol(UNII: 36W53O7109)
Petrolatum(UNII: 4T6H12BN9U)
Water(UNII: 059QF0KO0R)
Sodium Phosphate, Monobasic(UNII: 3980JIH2SW)
Phosphoric Acid(UNII: E4GA8884NN)
Propylene Glycol(UNII: 6DC9Q167V3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0462-0263-1515 g in 1 TUBE
2NDC:0462-0263-6060 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076973 09/01/2009
Aclovatealclometasone dipropionate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0462-0264
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alclometasone dipropionate(UNII: S56PQL4N1V)
(alclometasone dipropionate - UNII:S56PQL4N1V) 		alclometasone dipropionate0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Petrolatum(UNII: 4T6H12BN9U)
White Wax(UNII: 7G1J5DA97F)
Propylene Glycol Monostearate(UNII: F76354LMGR)
Hexylene Glycol(UNII: KEH0A3F75J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0462-0264-151 in 1 CARTON
115 g in 1 TUBE
2NDC:0462-0264-601 in 1 CARTON
260 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076884 10/01/2009

PRINCIPAL DISPLAY PANEL

NDC 0462-0263-60

PHARMADERM®

Aclovate® Cream, 0.05%

(alclometasone dipropionate cream)

For dermatologic use only – Not for ophthalmic use.

Rx only 60 g

Container Label

PRINCIPAL DISPLAY PANEL

NDC 0462-0263-60

PHARMADERM®

Aclovate® Cream, 0.05%

(alclometasone dipropionate cream)

For dermatologic use only – Not for ophthalmic use.

Rx only 60 g

Carton Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL

NDC 0462-0264-60

PharmaDerm®

Aclovate® Ointment, 0.05%

(alclometasone dipropionate ointment)

For dermatologic use only – Not for ophthalmic use.

Rx only

60 g

Container Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON

NDC 0462-0264-60

PharmaDerm®

Aclovate® Ointment, 0.05%

(alclometasone dipropionate ointment)

For dermatologic use only – Not for ophthalmic use.

Rx only

60 g

Carton Label