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.
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.)
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.
Dovonex® (calcipotriene cream) Cream, 0.005% is available in:
60 gram aluminum tubes NDC 54868-4725-0
Store at controlled room temperature 15° C — 25° C (59° F — 77° F). Do not freeze.
Manufactured by LEO Laboratories Ltd.
Warner Chilcott (US), LLC
Rockaway, NJ 07866 USA
U.S. Patent No. RE39,706 E
3020G012 Revised February 2008
Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146
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
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|
|Labeler — Physicians Total Care, Inc. (194123980)|
|Physicians Total Care, Inc.||194123980||relabel|
Revised: 11/2009 Physicians Total Care, Inc.
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