Calcipotriene
Calcipotriene is an FDA drug label for the active ingredient CALCIPOTRIENE manufactured by Prasco Laboratories administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20221212.
- Generic name
- CALCIPOTRIENE
- Manufacturer
- Prasco Laboratories
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 66993-877
- Application
- NDA020554
- Label effective
- 20221212
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 & Administration
DOSAGE AND 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.
Contraindications
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.
Warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Cream.
Adverse Reactions
ADVERSE REACTIONS