TACLONEX SCALP (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — CArton Label 60g

Carton Label for Taclonex Scalp 60 g
(click image for full-size original)

NDC 0430-3240-15

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 0.005% and betamethasone dipropionate 0.064% spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-3240
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
HYDROGENATED CASTOR OIL
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0430-3240-15 30 CARTON (CARTON) in 1 CASE contains a CARTON
1 1 BOTTLE (BOTTLE) in 1 CARTON This package is contained within the CASE (0430-3240-15) and contains a BOTTLE
1 60 g in 1 BOTTLE This package is contained within a CARTON and a CASE (0430-3240-15)
2 NDC:0430-3240-95 40 CARTON (CARTON) in 1 CASE contains a CARTON
2 1 BOTTLE (BOTTLE) in 1 CARTON This package is contained within the CASE (0430-3240-95) and contains a BOTTLE
2 15 g in 1 BOTTLE This package is contained within a CARTON and a CASE (0430-3240-95)
3 NDC:0430-3240-96 40 CARTON (CARTON) in 1 CASE contains a CARTON
3 1 BOTTLE (BOTTLE) in 1 CARTON This package is contained within the CASE (0430-3240-96) and contains a BOTTLE
3 4 g in 1 BOTTLE This package is contained within a CARTON and a CASE (0430-3240-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022185 06/01/2008
Labeler — Warner Chilcott (US), LLC (957203177)
Establishment
Name Address ID/FEI Operations
LEO Pharmaceutical Products Ltd. A/S 306218106 MANUFACTURE

Revised: 05/2008 Warner Chilcott (US), LLC

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