Drug Catalog - Product Detail
Calcipotriene Scalp Solution 0.00005 Topical Solution 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00115-1475-55 | AMNEAL PHARMACEUTICALS | 60 | 0.005% | SOLUTION |
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Description
DESCRIPTION Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless topical solution containing 0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and purified water. The chemical name of 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: 414f16cb-figure-01
How Supplied
HOW SUPPLIED Calcipotriene Topical Solution, 0.005% (Scalp Solution) is available in 60 mL plastic bottles (NDC 0115-1475-55). Storage and Handling Store at 20°to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid sunlight. Do not freeze. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006128 Rev. 0 12/18
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.