Drug Catalog - Product Detail
CALCIPOTRIENE OINTMENT 0.005% 120GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0310-66 | GLENMARK PHARMACEUTICALS | 120 | 0.005% | OINTMENT |
PACKAGE FILES
Generic Name
CALCIPOTRIENE
Substance Name
CALCIPOTRIENE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090633
Description
DESCRIPTION Calcipotriene Ointment USP, 0.005% contains the compound calcipotriene, USP a synthetic vitamin D 3 derivative for topical dermatological use. Chemically, calcipotriene, USP is24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-trioI; with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.62, and the following structural formula: Calcipotriene, USP is a white or almost white, crystalline powder. Calcipotriene Ointment USP, 0.005% contains calcipotriene, USP 50 mcg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, white petrolatum, propylene glycol, dl- alpha-tocopherol, steareth-2 and purified water. structure
How Supplied
HOW SUPPLIED Calcipotriene Ointment USP, 0.005% is available in: 60 gram aluminum tube NDC (68462-310-65) 120 gram aluminum tube NDC (68462-310-66)
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.