Taclonex (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

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TACLONEX® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment
Rx Only
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
Packaging
# 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. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 05/2012 Physicians Total Care, Inc.

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