Clocortolone Pivalate .001 g/g
Clocortolone Pivalate · CREAM · Taro Pharmaceuticals U.S.A., inc.
Clocortolone Pivalate is a cream containing clocortolone pivalate at .001 g/g, taken topical. Manufactured by Taro Pharmaceuticals U.S.A., inc..
Key Facts
- Brand Name
- Clocortolone Pivalate
- Generic Name
- Clocortolone Pivalate
- NDC Code (Product)
51672-4166- Manufacturer
- Taro Pharmaceuticals U.S.A., inc.
- Strength
- .001 g/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA206370
- Marketing Start
- 04/21/2020
Recall History
Dr. Reddy's Laboratories, Inc.
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
EPI Health, LLC
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
DOSAGE AND 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.
Contraindications
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
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
Frequently Asked Questions
What is Clocortolone Pivalate used for?
Clocortolone Pivalate contains Clocortolone Pivalate. It is a cream taken topical. Consult your doctor for specific uses.
Is Clocortolone Pivalate a controlled substance?
Clocortolone Pivalate is not classified as a controlled substance by the DEA.
What is the generic name for Clocortolone Pivalate?
The generic name for Clocortolone Pivalate is Clocortolone Pivalate. There are no other listed brand versions of Clocortolone Pivalate.
What is the NDC code for Clocortolone Pivalate .001 g/g?
The NDC (National Drug Code) for Clocortolone Pivalate .001 g/g is 51672-4166, listed by Taro Pharmaceuticals U.S.A., inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)