Cidacin Antifungal Treatment
Tolnaftate
Pedicis Research Llc
Human Otc Drug
NDC 51151-000Cidacin Antifungal Treatment also known as Tolnaftate is a human otc drug labeled by 'Pedicis Research Llc'. National Drug Code (NDC) number for Cidacin Antifungal Treatment is 51151-000. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Cidacin Antifungal Treatment drug includes Tolnaftate - 1 g/100mL . The currest status of Cidacin Antifungal Treatment drug is Active.
Drug Information:
| Drug NDC: | 51151-000 |
| 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: | Cidacin Antifungal Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Tolnaftate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pedicis Research Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | TOLNAFTATE - 1 g/100mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 07 Jun, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 2026 |
| 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: | part333C |
| 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: | Pedicis Research LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313423
1300375
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 06KB629TKV
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51151-000-01 | 1 BOTTLE in 1 CARTON (51151-000-01) / 15 mL in 1 BOTTLE | 05 Feb, 2017 | 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. |
Purpose:
Purpose antifungal
Product Elements:
Cidacin antifungal treatment tolnaftate dimethyl sulfoxide green tea leaf ascorbic acid povidone-iodine .alpha.-tocopherol acetate tolnaftate tolnaftate
Indications and Usage:
Uses for the cure of most ringworm (tinea orporis) and athletes foot (tinea pedis) fungal infections. for the relief of itching; burning; scaling; cracking; redness; soreness; irritation; discomfort that may accompany fungal infections.
Warnings:
Warnings for external use only. do not use on children unless directed by a doctor. when using this product avoid eye contact. if eye contact occurs, rinse thoroughly with water for 10-15 minutes. stop use and ask a doctor if if irritation occurs no improvement is seen 4 weeks. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. consult a physician before beginning treatment if pregnant/breast feeding.
Do Not Use:
Warnings for external use only. do not use on children unless directed by a doctor. when using this product avoid eye contact. if eye contact occurs, rinse thoroughly with water for 10-15 minutes. stop use and ask a doctor if if irritation occurs no improvement is seen 4 weeks. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. consult a physician before beginning treatment if pregnant/breast feeding.
When Using:
When using this product avoid eye contact. if eye contact occurs, rinse thoroughly with water for 10-15 minutes.
Dosage and Administration:
Directions clean affected area with soap and water, rinse and dry thoroughly. apply to affected areas twice daily (morning and night) or as directed by physician. supervise children in the use of the product. for athlete's foot: pay special attention to spaces between the toes. for athlete's foot and ringworm: use daily for 4 weeks. if condition persists longer, consult physician. formula will dry completely in several minutes without residue. change socks regularly at least once a daily. wear well-fitted, ventilated shoes.
Stop Use:
Stop use and ask a doctor if if irritation occurs no improvement is seen 4 weeks.
Package Label Principal Display Panel:
Professional dispensed only by physicians cidacin antifungal treatment professional advanced antifungal solution 15ml / 0.5 oz distributed by pedicis research llc radnor, pa 19087 patent pending
Cidacin antifungal treatment 15ml (51151-000-01) cidacin cidacin box
Further Questions:
Questions: call 1-800-748-6539