Drug Catalog - Product Detail
ALCLOMETASONE DIPROPIONATE CREAM USP 0.0005 15GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0300-17 | GLENMARK PHARMACEUTICALS | 15 | 0.05% | CREAM |
PACKAGE FILES
Generic Name
ALCLOMETASONE DIPROPIONATE
Substance Name
ALCLOMETASONE DIPROPIONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA079227
Description
DESCRIPTION Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate, USP is C 28 H 37 ClO 7 . It has the following structural formula: Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum. structure-formula
How Supplied
HOW SUPPLIED Alclometasone Dipropionate Cream USP, 0.05% is supplied in: 15 gram tubes (NDC 68462-300-17) 45 gram tubes (NDC 68462-300-47) 60 gram tubes (NDC 68462-300-65) Alclometasone Dipropionate Ointment USP, 0.05% is supplied in: 15 gram tubes (NDC 68462-299-17) 45 gram tubes (NDC 68462-299-47) 60 gram tubes (NDC 68462-299-65) Store between 2°C and 30°C (36°F and 86°F).
Indications & Usage
INDICATIONS AND USAGE Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin film of alclometasone dipropionate cream or ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream or ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Alclometasone dipropionate cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing. Geriatric Use : In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.