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| Product NDC Code | 65197-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Micatin |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 998483, 998509 |
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| Application Number | part333C | ||||
| Labeler Name | WellSpring Pharmaceutical Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT/INGREDIENTE ACTIVO Miconazole nitrate 2% / Nitrato de Miconazol 2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 / 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS/INGREDIENTES INACTIVOS benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water / aceite mineral, ácido benzoico, agua purificada, butilhidroxianisol, estearato de pegoxol 7, oleato de peglicol 5
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.PURPOSE/PROPÓSITO Antifungal/Antifúngico
Spl product data elements
Usually a list of ingredients in a drug product.Micatin Miconazole nitrate MICONAZOLE NITRATE MICONAZOLE BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL Tube Label
PACKAGE LABEL Inside Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.OTHER INFORMATION/OTRA INFORMACION do not use if seal on tube is punctured or not visible / No lo utilice si el sello del tubo esta punzado o no es visible to puncture the seal, reverse the cap and place the puncture-top onto the tube. Push down firmly until the seal is open. To close, screw the top back on the the tube. / Para perforar el sello, invierta la tapa y coloque la tapa con el punzador en el tubo. Oprima hacia abajo con firmeza hasta que el sello se abra. Para cerrar, enrosque la tapa al tubo store at 20º to 25ºC (68º to 77ºF) / Almacénelo de 20° a 25° C (68° a 77° F) see carton back panel and tube crimp for lot number and expiration date. / Vea el panel posterior de la caja y el tubo para ver el número de lote y fecha de vencimiento
DISTRIBUTED BY / DIST. WellSpring Pharmaceutical Corporation Sarasota, FL 34243 USA © WellSpring 2016 Made in Canada / Hecho en Canada
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS?/¿PREGUNTAS? 1-844-241-5454 www.micatin.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product / Al usar este producto avoid contact with the eyes / evite el contacto con los ojos
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API