Label: CONAZOL- miconazole nitrate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 75940-127-46 - Packager: MarcasUSA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 27, 2020
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- Official Label (Printer Friendly)
- Active Ingredients Purpose
- INDICATIONS & USAGE
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- 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
- use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
- if condition persists, consult a doctor
- this product is not effective on the scalp or nails
- in case of clogging, clear nozzle under running water
- Other Information
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Usos
- Precauciones
- Al utilizar este producto
- Deje de usar y consulte al médico, si
- Mantener fuera del alcance de los niños.
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Modo de empleo
- limpie y seque bien el área afectada
- agite bien el envase antes de usar
- aplique una capa fina del producto sobre el área afectada dos veces al día (mañana y noche) o según las indicaciones de un médico
- supervise a los niños en el uso de este producto
- para el pie de atleta, poner especial atención a los espacios entre los dedos de los pies, usar zapatos ventilados y cómodos, cambiar los calcetines y zapatos al menos una vez al día
- para el pie de atleta y tiña usar diariamente por 4 semanas
- para tiña inguinal, usar diariamente por 2 semanas
- si no hay mejora, consulte a su médico
- no es eficaz en el cuero cabelludo o las uñas
- en caso de obstrucción, limpiar boquilla bajo agua corriente
- Otra información
- Ingredientes Anactivos
- ¿Preguntas?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CONAZOL
miconazole nitrate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75940-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) ALCOHOL (UNII: 3K9958V90M) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75940-127-46 130 g in 1 CAN; Type 0: Not a Combination Product 06/25/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/25/2014 Labeler - MarcasUSA LLC (016139820) Establishment Name Address ID/FEI Business Operations Laboratorios Liomont, S.A. de C.V. 814377396 manufacture(75940-127)