Dovonex (Page 2 of 2)

ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse experiences reported for Dovonex® (calcipotriene cream) Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

OVERDOSAGE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

Apply a thin layer of Dovonex® Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex® Cream have been demonstrated in patients treated for eight weeks.

HOW SUPPLIED

Dovonex® (calcipotriene cream) Cream, 0.005% is available in:

60 gram aluminum tubes NDC 54868-4725-0

STORAGE

Store at controlled room temperature 15° C — 25° C (59° F — 77° F). Do not freeze.

LEO Laboratories Ltd. logo

LEO Laboratories Ltd. logo

Manufactured by LEO Laboratories Ltd.
Dublin, Ireland

Warner Chilcott logo

Marketed by:
Warner Chilcott (US), LLC
Rockaway, NJ 07866 USA
1-800-521-8813

U.S. Patent No. RE39,706 E

3020G062

3020G012 Revised February 2008

Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

image of 60 g package label
(click image for full-size original)

Dovonex®
(calcipotriene cream),
0.005% Cream

Rx only

WARNING: Keep Out of Reach of Children

Each gram contains 0.05 mg of
calcipotriene in a cream base of
cetearyl alcohol, ceteth-20,
diazolidinyl urea, dichlorobenzyl
alcohol, dibasic sodium phosphate,
edetate disodium, glycerin, mineral
oil, petrolatum, and water.

For Topical Dermatologic Use Only.
Not for Ophthalmic, Oral, or
Intravaginal Use.

Usual Dosage: Apply twice daily,
or as directed by physician. See
insert for complete information.
Read all Panels.

NET WT. 60 g

Store at controlled room temperature
15° C — 25° C (59° F — 77° F).
Do not freezeLot no. and expiration date on carton end and crimp of tube.

DOVONEX calcipotriene cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4725(NDC:0430-3020)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
CETETH-20
DICHLOROBENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
GLYCERIN
MINERAL OIL
PETROLATUM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4725-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (54868-4725-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020554 09/15/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 11/2009 Physicians Total Care, Inc.

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