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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:
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Indications And Usage:
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:BurningItchingIrritationDrynessFolliculitisHypertrichosisAcneiform eruptionsHypopigmentationPerioral dermatitisAllergic contact dermatitisMaceration of the skinSecondary infectionSkin atrophyStriaeMiliaria
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
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 or recalcitrant conditions.If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.
Clocortolone Pivalate Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes. 75 gram pump bottle NDC 66993-947-79 45 gram tube NDC 66993-947-48 90 gram tube NDC 66993-947-93
Store Clocortolone Pivalate Cream 0.1% between 15° and 30° C (59° and 86° F). Avoid freezing.
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