Taclonex Scalp (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

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Rx only

TACLONEX SCALP®
(calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension

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 mg of betamethasone) in a base of hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Store Taclonex Scalp® Topical Suspension between 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). Do not refrigerate. Keep the bottle in the outer carton when not in use. Shake before use.

Discard product three months after opening.

Keep out of the reach of children.

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

TACLONEX SCALP
calcipotriene and betamethasone dipropionate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6091(NDC:50222-501)
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) BETAMETHASONE DIPROPIONATE 0.643 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED CASTOR OIL
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6091-0 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 60 g in 1 BOTTLE This package is contained within the CARTON (54868-6091-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022185 12/10/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 08/2010 Physicians Total Care, Inc.

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