Miconazole Nitrate
Avpak
Human Otc Drug
NDC 50268-503Miconazole Nitrate is a human otc drug labeled by 'Avpak'. National Drug Code (NDC) number for Miconazole Nitrate is 50268-503. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Miconazole Nitrate drug includes Miconazole Nitrate - 20 mg/mL . The currest status of Miconazole Nitrate drug is Active.
Drug Information:
| Drug NDC: | 50268-503 |
| 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: | Miconazole Nitrate |
| 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: | Miconazole Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Avpak |
| 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: | MICONAZOLE NITRATE - 20 mg/mL
|
| 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: | 13 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | M005 |
| 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: | AvPAK
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998525
|
| 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: | VW4H1CYW1K
|
| 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: | Azole Antifungal [EPC]
Azoles [CS]
|
| 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 |
|---|
| 50268-503-29 | 29.57 mL in 1 BOTTLE (50268-503-29) | 13 Oct, 2022 | 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 topical antifungal
Product Elements:
Miconazole nitrate miconazole nitrate propylene glycol acetic acid laureth-4 sodium hydroxide miconazole nitrate miconazole sodium metabisulfite
Indications and Usage:
Uses cures most athleteâs foot (tinea pedis) and ring worm (tinea corporis). under professional supervision, miconazole nitrate 2% solution can be used for the treatment of superficial skin infections caused by yeast (candida albicans).
Warnings:
Warnings do not use on children under two years of age except under the advice and supervision of a doctor. for external use only. keep out of the reach of children. in case of accidental ingestion, seek professional assistance or contact poison control center immediately. avoid contact with eyes. if irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor or pharmacist. do not use if you are diabetic or have circulatory, renal, or hepatic problems, consult a doctor or pharmacist before using.
Dosage and Administration:
Directions cleanse and dry affected areas. apply a thin application twice a day (morning and night) on skin under nails and surrounding cuticle areas or as recommended by your doctor or pharmacist. remove miconazole nitrate 2% solution from any untreated areas. remove from all inanimate environmental surfaces. supervise children in the use of this product. for athleteâs foot, pay special attention to the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once a day. for athleteâs foot and ringworm use daily for 4 weeks. for fungal infections of the nail bed, if conditions persist, consult a doctor who may choose to debride or remove the nail to allow application of miconazole nitrate 2% solution to the skin of the nail bed. this product is not effective on the scalp or nails.
How Supplied:
How supplied ndc# 50268-503-29 1 fl. oz. (29.57ml) bottle with brush applicator containing an alcohol-free clear solution.
Package Label Principal Display Panel:
Principal display panel - 29.57 ml bottle carton 29
Further Questions:
Questions? frequently asked questions: what is the active ingredient in miconazole nitrate 2% solution? miconazole nitrate 2% solution contains 2% miconazole nitrate, the maximum strength antifungal allowed by the fda without a prescription. do i apply miconazole nitrate 2% solution to the nail? no, nothing penetrates nails. fungus is not growing on the nail but on the nail bed (skin). apply miconazole nitrate 2% solution on skin under nails and surrounding cuticle areas twice a day (morning and evening). when can i expect results? you may start seeing results in as little as 4 to 6 weeks. how long does it take for a nail to grow? it could take 8 to 10 months for a nail to grow out completely. why does your package say: âthis product is not effective on the scalp or nailsâ? in 1994, the fda ruled that no over-the-counter antifungal product is effective on the nails. the fdaâs opinion was that antifungal products available without a prescription could not penetrate the nails and are therefore, ineffective in treating them. the statement âthis product is not effective on scalp or nailsâ was subsequently required on the labels of all over-the-counter antifungal products. fungus is an infection of the skin, not the nail. can i use miconazole nitrate 2% solution for athleteâs foot? yes, miconazole nitrate 2% solution is a potent antifungal. it treats athleteâs foot and ringworm. for athleteâs foot and ringworm, apply miconazole nitrate 2% solution to the affected area twice a day for 4 weeks; pay special attention to spaces between the toes. can children use miconazole nitrate 2% solution? miconazole nitrate 2% solution is safe and effective for children over 2 years of age. children under 2 years of age, use only under physician supervision. what happens if miconazole nitrate 2% solution spills? care should be taken to avoid spilling because miconazole nitrate 2% solution may damage counter tops, porcelain, stainless steel, flooring, etc. for product questions, or to report a serious adverse event, call 1-855-361-3993.