Taclonex (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 60 g Tube Carton

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
(click image for full-size original)
TACLONEX calcipotriene 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 (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g
BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL, DL-
MINERAL OIL
PETROLATUM
POLYPROPYLENE GLYCOL 11 STEARYL ETHER
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50222-227-04 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (50222-227-04)
2 NDC:50222-227-81 1 TUBE in 1 CARTON contains a TUBE
2 100 g in 1 TUBE This package is contained within the CARTON (50222-227-81)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021852 06/01/2008 10/31/2024
Labeler — LEO Pharma Inc. (832692615)
Registrant — LEO Pharma A/S (306218108)
Establishment
Name Address ID/FEI Operations
LEO Laboratories Ltd. 219532322 ANALYSIS (50222-227), MANUFACTURE (50222-227), PACK (50222-227), LABEL (50222-227)

Revised: 05/2022 LEO Pharma Inc.

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