FDA Label for Clocortolone Pivalate Cream
View Indications, Usage & Precautions
Clocortolone Pivalate Cream Product Label
The following document was submitted to the FDA by the labeler of this product Prasco Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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:
Clinical Pharmacology:
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.
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
Acneiform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis
Maceration of the skin
Secondary infection
Skin atrophy
Striae
Miliaria
Overdosage:
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.
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 66993-947-79 |
45 gram tube | NDC 66993-947-48 |
90 gram tube | NDC 66993-947-93 |
Storage:
Store Clocortolone Pivalate Cream 0.1% between 15° and 30° C (59° and 86° F). Avoid freezing.
Principal Display Panel - 75 G
NDC 66993-947-79
RX ONLY
PRASCO
Clocortolone Pivalate Cream, 0.1%
For Topical Use Only
Pump
Net Wt 75 g
Principal Display Panel - 45 G
PRASCO
NDC 66993-947-48
RX ONLY
Clocortolone Pivalate Cream, 0.1%
For Topical Use Only
Net Wt 45 g
Principal Display Panel - 90 G
PRASCO
NDC 66993-947-93
RX ONLY
Clocortolone Pivalate Cream, 0.1%
For Topical Use Only
Net Wt 90 g
* Please review the disclaimer below.