Prednicarbate Recall

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FDA Labeling Changes

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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.


There is currently no drug history available for this drug.

Other Information

Prednicarbate emollient cream 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11β, 17, 21-trihydroxypregna-1,4-diene- 3,20-dione 17-(ethyl carbonate) 21- propionate. Prednicarbate has the empirical formula C27H36O8 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:

Chemical Structure

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.

Prednicarbate Manufacturers

  • Oceanside Pharmaceuticals
    Prednicarbate (Emollient) Cream [Oceanside Pharmaceuticals]
  • E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.
    Prednicarbate Cream [E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.]
  • Prasco Laboratories
    Prednicarbate Cream [Prasco Laboratories]

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