Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Calcipotriene Cream, 0.005% is available in: 60 gram aluminum tubes (NDC 66993-877-61) 120 gram aluminum tubes (NDC 66993-877-78); PRINCIPAL DISPLAY PANEL - 60 g Tube Carton NDC 66993-877-61 PRASCO Calcipotriene Cream, 0.005% Net Wt. 60 g Rx only PRINCIPAL DISPLAY PANEL - 60 g Tube Carton; Principal Display Panel - 120 g Tube Carton PRASCO NDC 66993-877-78 Calcipotriene Cream 0.005% Net Wt. 120 g Rx only Principal Display Panel - 120 g Tube Carton
- HOW SUPPLIED Calcipotriene Cream, 0.005% is available in: 60 gram aluminum tubes (NDC 66993-877-61) 120 gram aluminum tubes (NDC 66993-877-78)
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton NDC 66993-877-61 PRASCO Calcipotriene Cream, 0.005% Net Wt. 60 g Rx only PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
- Principal Display Panel - 120 g Tube Carton PRASCO NDC 66993-877-78 Calcipotriene Cream 0.005% Net Wt. 120 g Rx only Principal Display Panel - 120 g Tube Carton
Overview
Calcipotriene Cream, 0.005% contains calcipotriene monohydrate, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol monohydrate, with the empirical formula C 27 H 40 O 3 •H 2 O, a molecular weight of 430.6, and the following structural formula: Calcipotriene monohydrate is a white or off-white crystalline substance. Calcipotriene Cream contains calcipotriene monohydrate equivalent to 50 μg/g anhydrous calcipotriene in a cream base of cetearyl alcohol, ceteth-20, diazolidinyl urea, dichlorobenzyl alcohol, dibasic sodium phosphate, edetate disodium, dl-alpha tocopherol, glycerin, mineral oil, petrolatum, and water. Structural formula for calcipotriene monohydrate
Indications & 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 & Administration
Apply a thin layer of Calcipotriene Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Calcipotriene Cream have been demonstrated in patients treated for eight weeks.
Warnings & Precautions
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Cream.
Contraindications
Calcipotriene Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene Cream should not be used on the face.
Storage & Handling
STORAGE Store at controlled room temperature 15°C - 25°C (59°F - 77°F). Do not freeze.
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