Drug Catalog - Product Detail
PREDNICARBATE CREAM EMOLLIENT CRM 0.001 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0880-60 | OCEANSIDE PHARMACEUTICALS | 60 | 0.1% | CREAM |
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Description
DESCRIPTION Prednicarbate emollient cream 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11 β, 17, 21-trihydroxypregna-1,4-diene- 3,20-dione 17-(ethyl carbonate) 21- propionate. Prednicarbate has the empirical formula C 27 H 36 O 8 and a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The CAS Registry Number is 73771-04-7. The chemical structure is: Prednicarbate is a practically odorless white to yellow-white powder insoluble to practically insoluble in water and freely soluble in ethanol. Each gram of prednicarbate emollient cream 0.1% contains 1.0 mg of prednicarbate in a base consisting of white petrolatum USP, purified water USP, isopropyl myristate NF, lanolin alcohols NF, mineral oil USP, cetostearyl alcohol NF, aluminum stearate, edetate disodium USP, lactic acid USP, and magnesium stearate DAB 9. Chemical Structure
How Supplied
HOW SUPPLIED Prednicarbate emollient cream 0.1% is supplied in 60 g (NDC 68682-880-60) tubes. Store between 41° - 77°F (5° - 25°). Rx Only
Indications & Usage
INDICATIONS AND USAGE Prednicarbate emollient cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Prednicarbate emollient cream 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of prednicarbate emollient cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin film of prednicarbate emollient cream 0.1% to the affected skin areas twice daily. Rub in gently. Prednicarbate emollient cream 0.1% may be used in pediatric patients 1 year of age or older. Safety and efficacy of prednicarbate emollient cream 0.1% 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 the diagnosis may be necessary. Prednicarbate emollient cream 0.1% should not be used with occlusive dressings unless directed by the physician. Prednicarbate emollient cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.