Drug Catalog - Product Detail
DESOXIMETASONE TOPICAL 0.25% SPRAY 100ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0807-98 | PADAGIS | 100 | 0.25% | LIQUID |
PACKAGE FILES
Generic Name
DESOXIMETASONE
Substance Name
DESOXIMETASONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA206441
Description
11 DESCRIPTION Desoximetasone Topical Spray, 0.25% for dermatologic use contains desoximetasone as the active ingredient. Desoximetasone is a corticosteroid with the chemical name of pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11ß,16α)-. Desoximetasone has the molecular formula of C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is: Each gram of desoximetasone topical spray contains 2.5 mg of desoximetasone in a clear, colorless liquid with the following inactive ingredients: glyceryl oleate, isopropyl alcohol (23.4%), isopropyl myristate, L-menthol, and mineral oil. Desoximetasone topical spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied/Storage Desoximetasone Topical Spray, 0.25% is a clear colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following size: • 100 mL (NDC 45802- 807 -98) Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Spray is flammable; avoid heat, flame or smoking when using this product. Each unit is co-packaged with a manual spray pump for installation by the pharmacist. 16.2 Instructions for the Pharmacist 1. Remove the spray pump from the wrapper 2. Remove and discard the cap from the bottle 3. Keeping the bottle vertical, puncture seal, insert the spray pump into the bottle and turn clockwise until well-fastened 4. Dispense the bottle with the spray pump inserted 5. Label the bottle with “discard the product 30 days after dispensing”
Indications & Usage
1 INDICATIONS AND USAGE Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply desoximetasone topical spray as a thin film to the affected skin areas twice daily. Rub in gently. Do not bandage or otherwise cover or wrap the treated skin unless directed by the physician. Discontinue treatment when control is achieved. Treatment beyond 4 weeks is not recommended. Do not use if atrophy is present at the treatment site. Avoid use on the face, axilla or groin. Desoximetasone topical spray is for external use only. It is not for oral, ophthalmic, or intravaginal use. • Apply a thin film to the affected skin areas twice daily. Rub in gently. ( 2 ) • Discontinue treatment when control is achieved. ( 2 ) • Treatment beyond 4 weeks is not recommended. ( 2 ) • Do not use if atrophy is present at the treatment site. ( 2 ) • Do not use with occlusive dressings, unless directed by the physician. ( 2 ) • Avoid use on the face, axilla or groin. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )