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Drug Catalog - Product Detail

CLOCORTOLONE PIVALATE CREAM CRM PUMP 0.001 75GM

NDC Mfr Size Str Form
43598-0341-75 DR.REDDY'S LABORATORIES, INC. 75 0.1% NA
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PACKAGE FILES

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Generic Name
CLOCORTOLONE PIVALATE
Substance Name
CLOCORTOLONE PIVALATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA017765
Description
DESCRIPTION Clocortolone Pivalate Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β,21-dihydroxy-16α methylpregna-1,4-diene-3, 20-dione 21-pivalate.Its structure is as follows:
How Supplied
HOW SUPPLIED Clocortolone Pivalate Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes. 75 gram pump bottle NDC 43598-341-75 45 gram tube NDC 43598-341-45 90 gram tube NDC 43598-341-90
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply Clocortolone Pivalate Cream 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis orrecalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.