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Drug Catalog - Product Detail

CALCIPOTRIENE OINTMENT 0.005% 60GM

NDC Mfr Size Str Form
66993-0878-61 PRASCO LABORATORIES 60 0.005% OINTMENT
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Generic Name
CALCIPOTRIENE
Substance Name
CALCIPOTRIENE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA020273
Description
DESCRIPTION Calcipotriene Ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol-, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.6, and the following structural formula: Calcipotriene is a white or off-white crystalline substance. Calcipotriene Ointment contains calcipotriene 50 μg/g in an ointment base of dibasic sodium phosphate, edetate disodium, mineral oil, petrolatum, propylene glycol, tocopherol, steareth-2 and water. calcipotriene structure
How Supplied
HOW SUPPLIED Calcipotriene Ointment, 0.005% is available in: 60 gram aluminum tubes NDC 66993-878-61 120 gram aluminum tubes NDC 66993-878-78
Indications & Usage
INDICATIONS AND USAGE Calcipotriene Ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin layer of Calcipotriene Ointment once or twice daily and rub in gently and completely.