Drug Catalog - Product Detail
CALCIPOTRIENE CREAM 0.00005 120GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-7117-83 | SANDOZ | 120 | 0.005% | CREAM |
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Description
DESCRIPTION Calcipotriene Cream USP, 0.005% contains 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 0 3 , a molecular weight of 412.3, and the following structural formula: Calcipotriene is a white or off-white crystalline substance. Calcipotriene Cream, 0.005% contains calcipotriene equivalent to 50 mcg/g anhydrous calcipotriene in a cream base of ceteth-20, cetostearyl alcohol, diazolidinyl urea, dibasic sodium phosphate heptahydrate, 2,4-dichlorobenzyl alcohol, edetate disodium, glycerin, mineral oil, phosphoric acid, white petrolatum, sodium hydroxide and purified water. chemical structure
How Supplied
HOW SUPPLIED Calcipotriene Cream USP, 0.005% is available in: 60 gram aluminum tubes: NDC 0781-7117-35 120 gram aluminum tubes: NDC 0781-7117-83 Storage and Handling Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Do not freeze. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by Tolmar, Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 44473 Rev. 3 10/21
Indications & Usage
INDICATIONS AND USAGE Calcipotriene Cream, 0.005%, is indicated for the treatment of plaque psoriasis. 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 cream USP, 0.005% to the affected skin twice daily and rub in gently and completely. The safety and efficacy of calcipotriene cream, 0.005% have been demonstrated in patients treated for eight weeks.