NDC Code(s) : 0430-3020-17, 0430-3020-15, 0430-3020-95
Packager : Warner Chilcott (US), LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DovonexCalcipotriene CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-3020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE(UNII: 143NQ3779B)
(CALCIPOTRIENE - UNII:143NQ3779B) 		CALCIPOTRIENE50 ug in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETETH-20(UNII: I835H2IHHX)
DICHLOROBENZYL ALCOHOL(UNII: 1NKX3648J9)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-3020-1750 in 1 CASE
11 in 1 CARTON
1120 g in 1 TUBE
2NDC:0430-3020-15100 in 1 CASE
21 in 1 CARTON
260 g in 1 TUBE
3NDC:0430-3020-9525 in 1 CASE
312 in 1 CARTON
33 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020554 01/01/2006

PRINCIPAL DISPLAY PANEL

Carton Label for Dovonex Cream 120 g

Dovonex®
(calcipotriene cream),
0.005% Cream

Rx only

WARNING: Keep Out of Reach of Children

Each gram contains 0.05 mg of
calcipotriene in a cream base of
cetearyl alcohol, ceteth-20,
diazolidinyl urea, dichlorobenzyl
alcohol, dibasic sodium phosphate,
edetate disodium, glycerin, mineral
oil, petrolatum, and water.

For Topical Dermatologic Use Only.
Not for Ophthalmic, Oral, or
Intravaginal Use.

Usual Dosage: Apply twice daily,
or as directed by physician. See
insert for complete information.
Read all Panels.

NET WT. 120 g

Store at controlled room temperature
15° C - 25° C (59° F - 77° F).
Do not freeze
Lot no. and expiration date on carton end and crimp of tube.