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Drug Catalog - Product Detail

CALCIPOTRIENE TOPICAL SOLUTION SOL 0.00005 60ML

NDC Mfr Size Str Form
50383-0732-02 AKORN 60 0.005% SOLUTION
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Description
DESCRIPTION Calcipotriene Topical Solution, 0.005% (Scalp Solution), is a clear, colorless to light yellow topical solution containing calcipotriene monohydrate, a synthetic vitamin D 3 derivative, for topical dermatologic use. The chemical name of 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 Topical Solution, 0.005% (Scalp Solution) contains calcipotriene monohydrate equivalent to 50 μg/g anhydrous calcipotriene in a vehicle of hydroxypropyl cellulose, isopropyl alcohol (51% v/v), menthol, propylene glycol, purified water, and sodium citrate. Calcipotriene Structural Formula
How Supplied
HOW SUPPLIED Calcipotriene Topical Solution, 0.005% (Scalp Solution), is available in 60 mL plastic bottles. NDC 50383-732-02
Indications & Usage
INDICATIONS AND USAGE Calcipotriene Topical Solution, 0.005% (Scalp Solution), is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Dosage and Administration
DOSAGE AND ADMINISTRATION Comb the hair to remove scaly debris and after suitably parting, apply Calcipotriene Topical Solution, 0.005% (Scalp Solution), twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Calcipotriene Topical Solution, 0.005% (Scalp Solution), have been demonstrated in patients treated for eight weeks. Keep Calcipotriene Topical Solution, 0.005% (Scalp Solution), well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.