NDC Code(s) : 50222-227-04, 50222-227-81
Packager : LEO Pharma Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Taclonexcalcipotriene and betamethasone dipropionate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-227
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE MONOHYDRATE(UNII: S7499TYY6G)
(CALCIPOTRIENE - UNII:143NQ3779B) 		CALCIPOTRIENE50 ug in 1 g
BETAMETHASONE DIPROPIONATE(UNII: 826Y60901U)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
POLYPROPYLENE GLYCOL 11 STEARYL ETHER(UNII: S4G2J0Y0LG)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50222-227-041 in 1 CARTON 06/01/2008
160 g in 1 TUBE Type 0: Not a Combination Product
2NDC:50222-227-811 in 1 CARTON 06/01/2008
2100 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
NDA NDA021852 06/01/2008

LABELER - LEO Pharma Inc.(832692615)

REGISTRANT - LEO Pharma A/S(306218108)

Establishment
Name Address ID/FEI Business Operations
LEO Laboratories Ltd. 219532322 ANALYSIS(50222-227), MANUFACTURE(50222-227), PACK(50222-227), LABEL(50222-227)

PRINCIPAL DISPLAY PANEL

LEO®

NDC 50222-227-04

Rx only

Taclonex®
(calcipotriene 0.005% and
betamethasone
dipropionate 0.064%)
Ointment

For Topical Use Only

Net Wt. 60 g

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton