Drug Catalog - Product Detail
DESONIDE 0.05% GEL 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 24470-0920-60 | CINTEX | 60 | 0.05% | GEL |
PACKAGE FILES
Generic Name
DESONIDE
Substance Name
DESONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA202470
Description
11 DESCRIPTION Desonide Gel, 0.05% contains desonide [(pregna-1, 4-diene-3, 20-dione,11, 21-dihydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(11β,16α)]- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C 24 H 32 O 6 . It has the following structural formula: Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Gel, 0.05% contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium, methylparaben, propylparaben, sodium hydroxide, and Carbopol ® 974 P. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Desonide Gel, 0.05% is a translucent to opaque gel supplied in 60g tubes in cartons containing 1x 60g tube (NDC 24470-920-60). Storage: Store at controlled room temperature: 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Desonide Gel, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonide Gel, 0.05% for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonide Gel, 0.05% to suppress the hypothalamicpituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1 )]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration ( 2 )]. Desonide Gel, 0.05% is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer to the affected areas two times daily and rub in gently. Discontinue use when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Do not use with occlusive dressings. Avoid contact with eyes or other mucous membranes. For topical use only. Not for oral, ophthalmic, or intravaginal use. • Apply as a thin layer to the affected areas two times daily and rub in gently. ( 2 ) • Therapy should be discontinued when control is achieved. ( 2 ) • If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. ( 2 ) • Should not be used with occlusive dressings. ( 2 ) • Treatment beyond 4 consecutive weeks is not recommended. ( 2 ) • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 )