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| Product NDC Code | 52389-298 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Fungicure anti-fungal liquid |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| Application Number | M005 | ||||||
| Labeler Name | Alva-Amco Pharmacal Companies, Inc. | ||||||
| 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 Tolnaftate 1%
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 Read all package directions and warnings before use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Apply a thin layer of FUNGICURE Liquid over the affected area twice daily (morning and night), or as directed by a doctor. To prevent athlete's foot, wash the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). This product is not effective on scalp or nails. For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventillated shoes, and change shoes and socks at least once daily. Intended for use for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients BHT, Isopropyl alcohol, Polyethylene glycol
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 For the cure of most: ringworm (tinea corporis) athlete's foot (tinea pedis) For relief of: itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions Helps prevent most athlete's foot with daily use.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Fungicure Anti-Fungal Liquid Tolnaftate POLYETHYLENE GLYCOL 400 ISOPROPYL ALCOHOL TOLNAFTATE TOLNAFTATE BUTYLATED HYDROXYTOLUENE
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.Fungicure LiqPDP
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use on children under 2 years of age
Fungicure Anti-Fungal Liquid: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other Information FUNGICURE may be applied to exposed nail-beds, to cuticles, around nail edges and under nail tips where reachable with its applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces. While not all finger and toe fungal infections are curable with OTC topical medication, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained You may report serious side effects to the phone number provided under Questions? below.
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. If swallowed, get medical help or contact a poison control center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-792-2582 www.fungicure.com
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Insert Text Fungicure ANTI-FUNGAL LIQUID THE FINGER & TOE FUNGI SPECIALIST NOTHING STRONGER without an Rx Visible Results in as Little as 4 Weeks Kills 6 Types of Fungus WHAT IS FUNGUS INFECTION OF THE FINGER AND TOES? Common topical fungus infections of the finger and toes are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which thrive in dark, moist conditions. Using small breaches in the skin’s surface, these organisms can cause infection by contact with infected surfaces, animals, or people. Once infection starts, spreading may occur. For example, infected fingers and toes may infect other fingers and toes. Although such infections often develop slowly, they may be difficult to eliminate if not treated promptly with an effective anti-fungal medicine like FUNGICURE. HOW DO YOU KNOW IF YOU HAVE A TOPICAL FUNGUS INFECTION? Some topical fungal infections may present themselves on the skin surface as ring-like formations with clear centers; this is commonly called ringworm. Athlete’s foot fungus, when in the finger and toe areas, is often characterized by scaling of skin, burning, cracking, itching, and related discomforts. When nails become infected, they may appear to become opaque (cloudy white), thickened, brittle, easily broken, and in some cases, discolored (greenish/brown). UNDERSTANDING AND TREATING A NAIL AREA INFECTION: Fungal infections of the nail areas are often caused by the same fungi that lead to athlete’s foot and ringworm infections elsewhere on the body. These fungi can infect the entire area around the nails including the cuticles, the nail beds, and even the nails themselves. When infected finger/toe nails are intact, over-the-counter topical anti-fungal treatments may not be able to penetrate the nail and kill the fungus; this is why all OTC topical treatments must indicate they are not effective on the nails. However, in instances of advanced infection, the nails often are not intact; they may be missing, cracked open, or lifted away, exposing the infected nail bed. In these instances FUNGICURE Anti-Fungal Liquid, with its powerful anti-fungal formula, can reach and kill nail bed fungus by direct application or related capillary action. FUNGICURE cures the infection, allowing the natural regrowth of healthy looking tissue. NOTE: Fungal infections which are isolated beneath an intact nail or embedded within the nail itself may require consultation from a doctor for proper treatment. HOW FUNGICURE LIQUID WORKS: MAXIMUM STRENGTH FUNGICURE Liquid contains tolnaftate, a widely recognized anti-fungal ingredient that has been proven to be effective against 6 types of fungi such as E. floccosum, T. mentagrophytes, M. canis, M. gypseum, T. tonsurans and T. rubrum. When applied as directed, FUNGICURE Liquid acts promptly to target, destroy, and prevent the spread of infection by inhibiting the growth and reproduction of fungal cells. PROMPT ACTION AND PROPER TREATMENT: Early treatment of fungal infections is important. If you suspect that you may have a fungal infection, consult your doctor promptly for advice and proper diagnosis. You may wish to show him/her FUNGICURE Liquid and discuss its use. For best results, once treatment is started with FUNGICURE Liquid, it is important to carefully follow the treatment instructions on the package until satisfactory results are achieved or advised further by a doctor. NOTE: Noticeable improvement may be expected within 4 weeks in the case of most ringworm and athlete's foot fungus. Consult your doctor for advice if noticeable improvement is not evident by this time or if the condition persists or worsens. Active ingredient: Tolnaftate 1% Uses: For the cure of most: • ringworm (tinea corporis) • athlete’s foot (tinea pedis). For relief of: • itching • scaling • cracking • burning • redness • soreness • irritation • discomforts which may accompany these conditions. Helps prevent most athlete’s foot with daily use. Warnings: For external use only. Ask a doctor before use on children under 2 years of age. When using this product avoid contact with the eyes. Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. Directions: • Read all package directions and warnings before use. • Use only as directed. • Clean the affected area with soap and warm water and dry thoroughly. • Apply a thin layer of FUNGICURE Liquid over the affected area twice daily (morning and night), or as directed by a doctor. • To prevent athlete's foot, wash the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). • This product is not effective on scalp or nails. • For ringworm and athlete’s foot, use daily for 4 weeks. If condition persists longer, consult a doctor. • For athlete’s foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. • Intended for use by normally healthy adults only. • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. • Supervise children in the use of this product. Other information: • FUNGICURE may be applied to exposed nail beds, to cuticles, around nail edges and under nail tips where reachable with its applicator brush. • This product is not intended to, nor will it, penetrate hard nail surfaces. • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained. • You may report serious side effects to the phone number provided under Questions? below. Inactive ingredienst: BHT, isopropyl alcohol, polyethylene glycol. Questions? 1-800-792-2582 FUNGICURE.com The active ingredient in FUNGICURE has been recognized to be safe and effective by an FDA Expert Advisory Panel, when used as directed. Fungicure LÍQUIDO ANTIFÚNGICO Especialista en Hongos en Dedos de las Manos Y de los Pies NADA MÁS POTENTE sin receta Resultados visibles en an solo 4 semanas Elimina 6 tipos de hongos ¿QUÉ ES UNA INFECCIÓN MICÓTICA EN LOS DEDOS DE LAS MANOS Y DE LOS PIES? Las infecciones tópicas de hongos comunes en los dedos de las manos y de los pies son causadas por una variedad de hongos; organismos reales vivos (miembros de la familia de la levadura y el moho) que prosperan en condiciones oscuras y húmedas. Usando pequeñas hendiduras en la superficie de la piel, estos organismos pueden causar infección por el contacto con superficies infectadas, animales o personas. Una vez que empieza la infección, puede ocurrir una propagación. Por ejemplo, los dedos infectados de las manos y de los pies pueden infectar a otros dedos. Aunque dichas infecciones a menudo se desarrollan lentamente, pueden ser difíciles de eliminar si no son tratadas de inmediato con una medicina antifúngica efectiva como FUNGICURE. ¿CÓMO SE SABE SI SE TIENE UNA INFECCIÓN TÓPICA DE HONGOS? Algunas infecciones tópicas micóticas pueden presentarse sobre la superficie de la piel como formaciones tipo anillo con centros claros; esto comúnmente se llama tiña. Los hongos de pie de atleta, cuando están en las áreas de los dedos de las manos y de los pies, se caracterizan a menudo por escamas en la piel, ardor, agrietamiento, comezón y otras molestias relacionadas. Cuando se infectan las uñas, pueden lucir opacas (blanco opaco), más gruesas, quebradizas, se rompen fácilmente y en algunos casos, descoloridas (verdosas o cafés). COMPRENSIÓN Y TRATAMIENTO DE UNA INFECCIÓN EN EL ÁREA DE LAS UÑAS: Las infecciones micóticas del área de las uñas a menudo son causadas por los mismos hongos que causan el pie de atleta y las infecciones de tiña en otros lugares del cuerpo. Estos hongos pueden infectar el área completa alrededor de las uñas incluyendo las cutículas, los lechos ungueales y hasta las mismas uñas. Cuando las uñas de los dedos de las manos o de los pies infectadas están intactas, los tratamientos antifúngicos tópicos de venta libre (OTC) podrían no ser capaces de penetrar en la uña y eliminar el hongo; por esto es que todos los tratamientos tópicos de venta libre (OTC) deben indicar que no son efectivos en las uñas. Sin embargo, en ocasiones de infecciones avanzadas, las uñas a menudo no están intactas; el dedo puede ya no tener la uña, las uñas pueden estar abiertas o levantadas, exponiendo el lecho ungueal infectado. En estos casos, el Líquido antifúngico FUNGICURE, con su potente fórmula antifúngica, puede alcanzar y eliminar los hongos del lecho ungueal a través de una aplicación directa o de una acción capilar relacionada. FUNGICURE cura la infección, permitiendo el nuevo crecimiento natural del tejido de aspecto saludable. NOTA: Las infecciones micóticas que están aisladas dentro de una uña intacta o incrustadas dentro de la misma uña pueden requerir la consulta con un médico para recibir el tratamiento adecuado. CÓMO FUNCIONA EL LÍQUIDO FUNGICURE: El Líquido FUNGICURE de MÁXIMA CONCENTRACIÓN contiene tolnaftato, ingrediente antifúngico ampliamente reconocido que se ha comprobado efectivo contra 6 tipos de hongos tales como E. floccosum, T. mentagrophytes, M. canis, M. gypseum, T. tonsurans y T. rubrum. Si se aplica según las instrucciones, FUNGICURE líquido actúa de inmediato para atacar, destruir y evitar la propagación de la infección inhibiendo el crecimiento y la reproducción de las células micóticas. ACCIÓN INMEDIATA Y TRATAMIENTO ADECUADO: Es importante tratar a tiempo las infecciones micóticas. Si sospecha que puede tener una infección micótica, consulte con su médico de inmediato para recibir la asesoría y el diagnóstico adecuados. Tal vez quiera mostrarle el FUNGICURE Líquido y conversar sobre su uso. Para obtener mejores resultados, una vez que se inicia el tratamiento con FUNGICURE Líquido, es importante seguir cuidadosamente las instrucciones de tratamiento en el empaque hasta que haya logrado resultados satisfactorios o hasta recibir más recomendaciones de parte de su médico. NOTA: Puede esperarse una mejora notable en menos de 4 semanas en el caso de la mayoría de los hongos de tiña y pie de atleta. Consulte con su médico para recibir recomendaciones si no es evidente una mejora notable después de este tiempo o si la condición persiste o empeora. Ingrediente activo: Tolnaftato al 1 % Usos: Para curar la mayoría de los casos de: • tiña (tinea corporis) • pie de atleta (tinea pedis). Para aliviar: • comezón • descamación • agrietamiento ardor • enrojecimiento • dolor • irritación • incomodidades que pueden acompañar a estas condiciones. El uso diario ayuda a prevenir el pie de atleta en la mayoría los casos. Advertencias: Para uso externo solamente. Consulte con su médico antes de usarlo en niños menores de 2 años de edad. Cuando use este producto evite el contacto con los ojos. Descontinúe el uso y consulte a un médico si • ocurre irritación • no hay mejoría en menos de 4 semanas. Manténgalo fuera del alcance de los niños. Si es ingerido, obtenga asistencia médica o póngase en contacto de inmediato con un centro de control de envenenamiento. Instrucciones: • Lea todas las instrucciones y advertencias en el empaque antes del uso. • Úselo solo según las instrucciones. • Limpie el área afectada con jabón y agua tibia, y séquela completamente. • Aplique una capa fina de FUNGICURE Líquido sobre el área afectada dos veces por día (en la mañana y en la noche) o según lo indique el médico. • Para prevenir el pie de atleta, lávese los pies y séquelos completamente. Aplique una capa fina del producto en los pies una o dos veces por día (mañana y/o noche). • Este producto no es efectivo sobre el cuero cabelludo o las uñas. • Contra la tiña y el pie de atleta, usar todos los días por 4 semanas. Si la condición persiste, consulte a su médico. • Para el tratamiento del pie de atleta, ponga atención especial a los espacios entre los dedos de los pies, utilice zapatos con ventilación que le queden bien, y cámbiese los zapatos y las medias por lo menos una vez por día. • Diseñado para usarlo en adultos normalmente saludables. • Las personas menores de 18 años de edad o aquellas con piel alérgica o altamente sensible deben usarlo solo según las instrucciones del médico. Supervise a los niños en el uso de este product. Otra información: • FUNGICURE se puede aplicar a los lechos ungueales expuestos, las cuticulas, alrededor de los bordes de la uña y debajo de las puntas de las uñas que se puedan alcanzar con el cepillo aplicador. • Este producto no está previsto para las superficies duras de las uñas ni logrará penetrarlas. Aunque no todas las infecciones micóticas de los dedos de la mano y de los pies son curables con medicamentos tópicos de venta libre, si nota una mejoría en menos de 4 semanas de uso, puede continuar utilizando FUNGICURE hasta que obtenga resultados satisfactorios. • Puede reportar efectos secundarios serios al número telefónico provisto en ¿Preguntas? que aparece a continuación. Ingrediente inactivo: BHT, alcohol isopropílico, polietilenglicol. ¿Preguntas? 1-800-792-2582 FUNGICURE.com El ingrediente activo en FUNGICURE ha sido reconocido como seguro y efectivo por un Panel consultivo de expertos de la FDA, cuando se usa según las instrucciones.
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 irritation occurs there is no improvement within 4 weeks
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 avoid contact with the eyes.
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 For external use only
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