RVP

Drug Catalog - Product Detail

SORILUX CALCIPOTRIENE FOAM 0.005% 60GM

NDC Mfr Size Str Form
51862-0376-60 MAYNE PHARMA 60 0.005% FOAM
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Generic Name
CALCIPOTRIENE
Substance Name
CALCIPOTRIENE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA022563
Description
11 DESCRIPTION SORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog, in an aqueous-based emulsion foam vehicle for topical dermatologic use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene- 1α,3β,24-triol. The structural formula is represented below: Molecular Formula: C27H40O3 Molecular Weight: 412.6 Calcipotriene is a white or off-white crystalline substance. SORILUX Foam contains calcipotriene 50 mcg/g in an aqueous-based emulsion foam vehicle consisting of cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. SORILUX Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SORILUX (calcipotriene) Foam, 0.005%, is supplied as follows: 120 g aluminum can NDC 51862-376-12 16.2 Storage and Handling Store at 20ºC to 25°C (68°F to 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). Flammable. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION SORILUX Foam is for topical use only. SORILUX Foam is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of SORILUX Foam twice daily to the affected areas and rub in gently and completely. Avoid contact with the face and eyes. For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply twice daily. ( 2 )