NDC Code(s) : 51672-1306-1, 51672-1306-6, 51672-1306-3
Packager : Sun Pharmaceutical Industries, 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:51672-1306
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
CETETH-20(UNII: I835H2IHHX)
CETYL ALCOHOL(UNII: 936JST6JCN)
CHLOROCRESOL(UNII: 36W53O7109)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(UNII: 3980JIH2SW)
PEG-100 STEARATE(UNII: YD01N1999R)
PHOSPHORIC ACID(UNII: E4GA8884NN)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51672-1306-11 in 1 CARTON 15/09/2005
115 g in 1 TUBE Type 0: Not a Combination Product
2NDC:51672-1306-61 in 1 CARTON 15/09/2005
245 g in 1 TUBE Type 0: Not a Combination Product
3NDC:51672-1306-31 in 1 CARTON 15/09/2005
360 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076587 09/15/2005

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharma Canada Inc. 243339023 manufacture(51672-1306)

PRINCIPAL DISPLAY PANEL

Alclometasone Dipropionate
Cream USP, 0.05%

FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

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