TACLONEX (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — CARTON LABEL 100 g

Taclonex Ointment Carton Label 100 g
(click image for full-size original)

NDC 0430-3230-16
TACLONEX® ( calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment

Rx only

For Topical Use Only

Net Wt. 100 g

Each gram contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.

Store Taclonex® Ointment between 20 — 25° C (68 — 77° F); excursions permitted between 15 — 30° C (59 — 86° F).

Keep out of reach of children.

Usual Dosage: Apply once daily, or as directed by physician. See Insert for complete information.

TACLONEX
calcipotriene and betamethasone dipropionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-3230
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g
BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE 0.643 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
ALPHA-TOCOPHEROL, DL-
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0430-3230-15 100 CARTON (CARTON) in 1 CASE contains a CARTON
1 1 TUBE (TUBE) in 1 CARTON This package is contained within the CASE (0430-3230-15) and contains a TUBE
1 60 g in 1 TUBE This package is contained within a CARTON and a CASE (0430-3230-15)
2 NDC:0430-3230-16 50 CARTON (CARTON) in 1 CASE contains a CARTON
2 1 TUBE (TUBE) in 1 CARTON This package is contained within the CASE (0430-3230-16) and contains a TUBE
2 100 g in 1 TUBE This package is contained within a CARTON and a CASE (0430-3230-16)
3 NDC:0430-3230-95 25 CARTON (CARTON) in 1 CASE contains a CARTON
3 10 TUBE (TUBE) in 1 CARTON This package is contained within the CASE (0430-3230-95) and contains a TUBE
3 3 g in 1 TUBE This package is contained within a CARTON and a CASE (0430-3230-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021852 06/01/2008
Labeler — Warner Chilcott (US), LLC (957203177)
Establishment
Name Address ID/FEI Operations
LEO Laboratories Ltd. (LEO Pharma) 306218106 MANUFACTURE

Revised: 12/2009 Warner Chilcott (US), LLC

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