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NDC 65197-0103-05 Micatin 20 mg/g Details
Micatin 20 mg/g
Micatin is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by WellSpring Pharmaceutical Corporation. The primary component is MICONAZOLE NITRATE.
MedlinePlus Drug Summary
Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.
Related Packages: 65197-0103-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Topical
Product Information
| NDC | 65197-0103 |
|---|---|
| Product ID | 65197-103_89b3a546-fbdc-4c1d-96af-c4f83be1f6d2 |
| Associated GPIs | 90154050103705 |
| GCN Sequence Number | 007366 |
| GCN Sequence Number Description | miconazole nitrate CREAM (G) 2 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 30400 |
| HICL Sequence Number | 003031 |
| HICL Sequence Number Description | MICONAZOLE NITRATE |
| Brand/Generic | Generic |
| Proprietary Name | Micatin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Miconazole nitrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | MICONAZOLE NITRATE |
| Labeler Name | WellSpring Pharmaceutical Corporation |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 65197-0103-05 (65197010305)
| NDC Package Code | 65197-103-05 |
|---|---|
| Billing NDC | 65197010305 |
| Package | 14 g in 1 TUBE (65197-103-05) |
| Marketing Start Date | 2009-06-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 96c56ba1-c3a8-48ce-ab58-550959485e3c Details
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
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
DISTRIBUTED BY / DIST.
INGREDIENTS AND APPEARANCE
| MICATIN
miconazole nitrate cream |
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| Labeler - WellSpring Pharmaceutical Corporation (110999054) |
Revised: 4/2016
Document Id: 89b3a546-fbdc-4c1d-96af-c4f83be1f6d2
Set id: 96c56ba1-c3a8-48ce-ab58-550959485e3c
Version: 9
Effective Time: 20160407