Micatin

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: WellSpring Pharmaceutical Corporation
NDC Code: 65197-103

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.

Micatin

ACTIVE INGREDIENT/INGREDIENTE ACTIVO

Miconazole nitrate 2% / Nitrato de Miconazol 2%

PURPOSE/PROPÓSITO

Antifungal/Antifúngico

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/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.

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

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

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

QUESTIONS?/¿PREGUNTAS?

1-866-337-4500 info@wellspringpharm.com /

1-866-337-4500 info@wellspringpharm.com

DISTRIBUTED BY / DIST.

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA

© WellSpring 2010

Made in Canada / Hecho en Canada

PACKAGE LABEL

PACKAGE LABEL

MICATIN 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65197-103-0514 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C06/24/2009
Labeler - WellSpring Pharmaceutical Corporation (110999054)
Establishment
NameAddressID/FEIOperations
WellSpring Pharmaceutical Canada Corp.251086799ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 01/2011
 
WellSpring Pharmaceutical Corporation

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.

Hide
(web4)