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| Product NDC Code | 63347-800 | ||||
|---|---|---|---|---|---|
| Drug Name | Vite20 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M005 | ||||
| Labeler Name | Blaine Labs 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.Ingrediente Activo Active Ingredients INGREDIENTE ACTIVO: Acido Undecilenico 10 % Active Ingredient: Undecylenic Acid 10%
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.Modo De Empleo Directions MODO DE EMPLEO: Lave con aqua y jabon ;as areas afectadas y sequelas adecuadamente. Aplique una capa ligera dos veces al dia (manana y noche), o como lo haya indicado su medico. Los ninos menores de 12 anos que usen este producto deberan hacerlo bajo estricta supervision de un adulto. En los casos de pie de atleta, debe poner atencion entre los dedos de los pies. Es recomendable que use zapatos a la medida y bien ventilados, y cambiarse de calcentines y zapatos cuando menos una vez al dia. Para el pie de atleta y la tina, use diario por cuatro semanas; papa comezon en la ingle, does semanas son suficentes. Si no obtiene resultados en el tiemp indicado, es mejor consultar con su medico. DIRECTIONS: wash the affected area with soap and water and dry thoroughly. Apply sparingly over affected area twice daily (morning and night), or as directed by a physician. For athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a physician. This product is not effective on scalp or nails. Supervise children in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Otros Ingredientes Inactive Ingredients OTROS INGREDIENTES: Savila, Alcohol Cetilico, Clotrimazole, Caprilate de Coco, Acido Etilendiamino Tetraacetico, Estearato de Glicerilo, Celulosa Hidroxilada, Aceite de Lavanda. Metilparabeno, Polietileno de Glicol de Estearato 100, Polisorbato 60, Propilparabeno, Acido Estearico, Melaleuca, Trietanolamina, Urea, Agua. INACTIVE INGREDIENTS: Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearic, Hydroxyethylcellulose, lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.
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.Usos USES USOS: Cura el pie de (tinea pedis), comezon en la ingle (tinea cruris) y tina (tinea corporis). Par alivio effectivo de la comezon, agrietamiento, ardor y molestias asociadas con estas enfermedades. USES:Cures athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm(tinea corpois). For effective relief of itching, cracking, burning and discomfort that can accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose CREMA ANTIHONGOS Antifungal Cream
Spl product data elements
Usually a list of ingredients in a drug product.Vite20 UNDECYLENIC ACID UNDECYLENIC ACID UNDECYLENIC ACID ALOE VERA LEAF CETYL ALCOHOL CLOTRIMAZOLE COCO-CAPRYLATE EDETATE DISODIUM GLYCERYL MONOSTEARATE HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) LAVENDER OIL METHYLPARABEN PEG-100 STEARATE POLYSORBATE 60 PROPYLPARABEN STEARIC ACID TEA TREE OIL TROLAMINE UREA WATER
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 VITE20 CREMA ANIHONGOS Cont. Neto 20 ml para manos y pies saludables Blaine labs, Inc. Santa Fe Springs, CA 90670, U.S.A. (800) 307-8818 PNE-V20AR Rev. 20120229 Blaine Vite20 Label
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.Precauciones Keep Out Of Reach Of Children Mantenga este y todos los medicamentos fuera del alcance de los ninos. En caso de ingestion accidental, comuniquese con el centro de salud mas cercano y pida ayuda profesional inmediatamente. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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.Precauciones Warnings PRECAUCIONES: No debe aplicarse en menores de 2 anos, excepto cuando su medico lo recomiende. Para uso externo unicamente. Evite el contacto con los olos. Si observa alguna irritacion, o si no hay mejoria despues de cuatro semanas (en el pie de atleta o en la tina), o dos semanas (en la comezon el la ingle), suspenda su uso y consulte a su medico. Mantenga este y todos los medicamentos fuera del alcance de los ninos. En caso de ingestion accidental, comuniquese con el centro de salud mas cercano y pida ayuda profesional inmediatamente. WARNINGS: Do not use on children under 2 years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a physician. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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