Clocortolone Pivalate CLOCORTOLONE PIVALATE TARO PHARMACEUTICALS U.S.A., INC. FDA Approved Clocortolone pivalate cream USP, 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of benzyl alcohol, carbomer homopolymer Type B (carbopol 974P), edetate disodium, methylparaben, mineral oil, polyoxyl 40 stearate (MYRJ 40S), propylparaben, purified water, sodium hydroxide, stearyl alcohol and white petrolatum. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16αmethylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: Chemical Structure
FunFoxMeds box
Route
TOPICAL
Applications
ANDA206370

Drug Facts

Composition & Profile

Strengths
0.1 % 45 g 90 g
Quantities
6 count 8 count
Treats Conditions
Indications And Usage Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOX
UNII
QBL8IZH14X
Packaging

HOW SUPPLIED Clocortolone Pivalate Cream USP, 0.1% is supplied in 45 gram and 90 gram tubes. 45 gram tube NDC 51672-4166-6 90 gram tube NDC 51672-4166-8 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.; PRINCIPAL DISPLAY PANEL - 90 g Tube Carton NDC 51672-4166-8 90 g Clocortolone Pivalate Cream USP, 0.1% For Topical Use Only Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

Package Descriptions
  • HOW SUPPLIED Clocortolone Pivalate Cream USP, 0.1% is supplied in 45 gram and 90 gram tubes. 45 gram tube NDC 51672-4166-6 90 gram tube NDC 51672-4166-8 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
  • PRINCIPAL DISPLAY PANEL - 90 g Tube Carton NDC 51672-4166-8 90 g Clocortolone Pivalate Cream USP, 0.1% For Topical Use Only Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

Overview

Clocortolone pivalate cream USP, 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of benzyl alcohol, carbomer homopolymer Type B (carbopol 974P), edetate disodium, methylparaben, mineral oil, polyoxyl 40 stearate (MYRJ 40S), propylparaben, purified water, sodium hydroxide, stearyl alcohol and white petrolatum. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16αmethylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: Chemical Structure

Indications & Usage

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Apply clocortolone pivalate cream USP, 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.

Warnings & Precautions
No warnings available yet.
Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

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: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

Storage & Handling

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.


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