Ciclopirox Olamine
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-8624Ciclopirox Olamine is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Ciclopirox Olamine is 63629-8624. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Ciclopirox Olamine drug includes Ciclopirox Olamine - 7.7 mg/g . The currest status of Ciclopirox Olamine drug is Active.
Drug Information:
| Drug NDC: | 63629-8624 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ciclopirox Olamine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ciclopirox Olamine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bryant Ranch Prepack |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CICLOPIROX OLAMINE - 7.7 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 19 Jul, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA077364 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Bryant Ranch Prepack
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309289
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 50MD4SB4AP
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased DNA Replication [PE]
Decreased Protein Synthesis [PE]
Decreased RNA Replication [PE]
Protein Synthesis Inhibitors [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63629-8624-1 | 1 TUBE in 1 CARTON (63629-8624-1) / 15 g in 1 TUBE | 05 Sep, 2006 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Ciclopirox olamine ciclopirox olamine ciclopirox olamine ciclopirox benzyl alcohol cetyl alcohol lactic acid, unspecified form light mineral oil myristyl alcohol octyldodecanol polysorbate 60 water sorbitan monostearate stearyl alcohol chemical structure image
Indications and Usage:
Indications and usage ciclopirox olamine cream usp, 0.77% 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.
Warnings:
Warnings general - ciclopirox olamine cream usp, 0.77% is not for ophthalmic use. keep out of reach of children.
Dosage and Administration:
Dosage and administration gently massage ciclopirox olamine cream usp, 0.77% 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 usp, 0.77% the diagnosis should be redetermined. patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
Contraindications:
Contraindications ciclopirox olamine cream usp, 0.77% 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 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.
Pediatric Use:
Pediatric use - safety and effectiveness in pediatric patients below the age of 10 years have not been established.
Description:
Description ciclopirox olamine cream usp, 0.77% is for topical use. each gram of ciclopirox olamine cream usp, 0.77% contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible, vanishing cream base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. ciclopirox olamine cream usp, 0.77% contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). the chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 h )-pyridone,2-aminoethanol salt. the cas registry number is 41621-49-2. the chemical structure is : ciclopirox olamine cream usp, 0.77% has a ph of 7.
Clinical Pharmacology:
Clinical pharmacology ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and malassezia furfur. ciclopirox exhibits fungicidal activity in vitro against isolates of trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum, microsporumcanis, and candida albicans. pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm 2 on the back followed by occlusion for 6 hours. the biological half-life was 1.7 hours and excretion occurred via the kidney. two days after application only 0.01% of the dose applied could be found in the urine. fecal excretion was negligible. penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. the levels in the
Read more... dermis were still 10 to 15 times above the minimum inhibitory concentrations. autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum. draize human sensitization assay, 21-day cumulative irritancy study, phototoxicity study, and photo-draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility - a carcinogenicity study in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site. the following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the ames salmonella/ mammalian microsome assay (negative) and yeast saccharomyces cerevisiae assay (negative) and studies to evaluate chromosome aberrations in vivo in the mouse dominant lethal assay and in the mouse micronucleus assay at 500 mg/kg (negative). the following battery of in vitro genotoxicity tests were conducted with ciclopirox: a chromosome aberration assay in v79 chinese hamster cells, with and without metabolic activation (positive); a gene mutation assay in the hgprt - test with v79 chinese hamster cells (negative); and a primary dna damage assay (i.e., unscheduled dna synt
Read more...hesis assay in a549 human cells (negative)). an in vitro cell transformation assay in balb/c3t3 cells was negative for cell transformation. in an in vivo chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.
How Supplied:
How supplied ciclopirox olamine cream usp, 0.77% is available as follows: 15 g tube (ndc 63629-8624-1)
Information for Patients:
Information for patients the patient should be told to: 1. use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks. 2. inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization. 3. avoid the use of occlusive wrappings or dressings.
Package Label Principal Display Panel:
Ciclopirox olamine 0.77% cream, #15 label