Vite20

Dosage form: cream
Ingredients: UNDECYLENIC ACID 2mL in 20mL
Labeler: Blaine Labs Inc.
NDC Code: 63347-800

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Ingrediente Activo Active Ingredients

INGREDIENTE ACTIVO: Acido Undecilenico 10 %

Active Ingredient: Undecylenic Acid 10%

Purpose

CREMA ANTIHONGOS

Antifungal Cream

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.

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.

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.

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.

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.

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

VITE20 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-800
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID2 mL  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:63347-800-0120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/2012
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture

Revised: 03/2012
 
Blaine Labs Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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