Ciclopirox olamine 7.7 mg/g
Ciclopirox olamine · CREAM · Bryant Ranch Prepack
Ciclopirox olamine is a cream containing ciclopirox olamine at 7.7 mg/g, taken topical. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Ciclopirox olamine
- Generic Name
- Ciclopirox olamine
- NDC Code (Product)
63629-8626- Manufacturer
- Bryant Ranch Prepack
- Strength
- 7.7 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA077364
- Marketing Start
- 07/19/2006
Recall History
G & W Laboratories, Inc.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
G & W Laboratories, Inc.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
Dosage & Administration
DOSAGE AND ADMINISTRATION Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
Warnings
WARNINGS Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.
Contraindications
CONTRAINDICATIONS Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
Adverse Reactions
ADVERSE REACTIONS In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is Ciclopirox olamine used for?
Ciclopirox olamine contains Ciclopirox olamine. It is a cream taken topical. Consult your doctor for specific uses.
Is Ciclopirox olamine a controlled substance?
Ciclopirox olamine is not classified as a controlled substance by the DEA.
What is the generic name for Ciclopirox olamine?
The generic name for Ciclopirox olamine is Ciclopirox olamine. There are 10 other brand versions of Ciclopirox olamine.
What is the NDC code for Ciclopirox olamine 7.7 mg/g?
The NDC (National Drug Code) for Ciclopirox olamine 7.7 mg/g is 63629-8626, listed by Bryant Ranch Prepack.
Other Ciclopirox olamine Dosages
Other Ciclopirox Brands
See all →- Ciclopirox Olamine7.7 mg/g72162-1397
- Ciclopirox Olamine7.7 mg/g80425-0225
- Ciclopirox Olamine7.7 mg/100mL63629-8627
- Ciclopirox Olamine7.7 mg/100mL71335-2717
- Ciclopirox Olamine7.7 mg/g63629-8624
- Ciclopirox Olamine7.7 mg/100mL71335-2915
- Ciclopirox Olamine7.7 mg/g63629-8625
- Ciclopirox Olamine7.7 mg/g68462-297
- Ciclopirox Olamine7.7 mg/100mL72162-1406
- Ciclopirox Olamine7.7 mg/g51672-1318
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)