Micatin
Miconazole Nitrate
Wellspring Pharmaceutical Corporation
Human Otc Drug
NDC 65197-103Micatin also known as Miconazole Nitrate is a human otc drug labeled by 'Wellspring Pharmaceutical Corporation'. National Drug Code (NDC) number for Micatin is 65197-103. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Micatin drug includes Miconazole Nitrate - 20 mg/g . The currest status of Micatin drug is Active.
Drug Information:
| Drug NDC: | 65197-103 |
| 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: | Micatin |
| 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: | Wellspring Pharmaceutical Corporation |
| 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: | MICONAZOLE NITRATE - 20 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: | 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: | 24 Jun, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | 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: | WellSpring Pharmaceutical Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998483
998509
|
| 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 |
|---|
| 65197-103-05 | 14 g in 1 TUBE (65197-103-05) | 24 Jun, 2009 | 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/propÓsito antifungal/antifúngico
Product Elements:
Micatin miconazole nitrate miconazole nitrate miconazole benzoic acid butylated hydroxyanisole mineral oil
Indications and Usage:
Uses/usos proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm / comprobado clínicamente para el tratamiento de la mayoría de los casos de pie de atleta, la sarna deportiva y la tiña for effective relief of itching, scaling, burning and discomfort that can company these conditions / para el alivio efectivo de picazón, descamación, ardor y las molestias que pueden acompañar estas condiciones
Warnings:
Warnings/advertencias for external use only / para uso externo únicamente do not use on children less than 2 years of age unless directed by a doctor / no administre en niños menores de 2 años, a menos que indicado por un médico when using this product / al usar este producto avoid contact with the eyes / evite el contacto con los ojos stop use and ask a doctor if / pare el uso y consulte a un médico irritation occurs / si se produce irritación condition persists / condiciones persisten there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks / si no se mejora el pie de atleta o tiña en 4 semanas o la sarna deportiva en 2 semanas keep out of reach of children. mantenga fuera del alcance de los niños, if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222) / en caso de ingestión, obtenga ayuda médica o póngase en contacto con el centro de control de envenenamiento inmediatamente.
Do Not Use:
Warnings/advertencias for external use only / para uso externo únicamente do not use on children less than 2 years of age unless directed by a doctor / no administre en niños menores de 2 años, a menos que indicado por un médico when using this product / al usar este producto avoid contact with the eyes / evite el contacto con los ojos stop use and ask a doctor if / pare el uso y consulte a un médico irritation occurs / si se produce irritación condition persists / condiciones persisten there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks / si no se mejora el pie de atleta o tiña en 4 semanas o la sarna deportiva en 2 semanas keep out of reach of children. mantenga fuera del alcance de los niños, if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222) / en caso de ingestión, obtenga ayuda médica o póngase en contacto con el centro de control de envenenamiento inmediatamente.
When Using:
When using this product / al usar este producto avoid contact with the eyes / evite el contacto con los ojos
Dosage and Administration:
Directions/instrucciones clean the affected area and dry thoroughly / lave el área afectada y seque bien apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor / aplique una capa delgada del producto sobre el área afectada dos veces al día (mañana y noche) o según las indicaciones de un médico supervise children in the use of this product / supervise a los niños en la administración de este producto for athlete's foot, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily / para el pie de atleta ponga especial atención en los espacios entre los dedos, es recomendable llevar zapatos bien ajustados que permitan la ventilación y cambie de zapatos y calcetines al menos una vez al día for athlete's foot and ringworm, use daily for 4 weeks / para el pie de atleta y la tiña, utilice a diario por 4 semanas for jock itch, use daily for 2 weeks
Read more.../ para la sarna deportiva, utilice a diario por 2 semanas not effective on the scalp or nails / no es efectivo en el cuero cabelludo y en las uñas
Stop Use:
Stop use and ask a doctor if / pare el uso y consulte a un médico irritation occurs / si se produce irritación condition persists / condiciones persisten there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks / si no se mejora el pie de atleta o tiña en 4 semanas o la sarna deportiva en 2 semanas
Package Label Principal Display Panel:
Package label tube label
Package label inside label
Further Questions:
Questions?/¿preguntas? 1-844-241-5454 www.micatin.com