PRINCIPAL DISPLAY PANEL
TACLONEX® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment
For Topical Use Only
Net Wt. 60 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 mcg 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:54868-5680(NDC:50222-227) |
|Route of Administration ||TOPICAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|CALCIPOTRIENE HYDRATE (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 || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:54868-5680-0 ||100 CARTON (CARTON) in 1 CASE ||contains a CARTON |
| 1 || ||1 TUBE (TUBE) in 1 CARTON ||This package is contained within the CASE (54868-5680-0) and
contains a TUBE |
| 1 || ||60 g in 1 TUBE ||This package is contained within a CARTON and a CASE (54868-5680-0) |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|NDA ||NDA021852 ||10/20/2010 || |
|Labeler — Physicians Total Care, Inc.
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Physicians Total Care, Inc. || ||194123980 ||relabel |
Revised: 05/2012 Physicians Total Care, Inc.
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