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| Product NDC Code | 83592-580 | ||||
|---|---|---|---|---|---|
| Drug Name | Miconi-al |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 998525 | ||||
| Application Number | M005 | ||||
| Labeler Name | True Marker Pharmaceuticals, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (s) Miconazole Nitrate 2%
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.Directions clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily Supervise children in the use of this product 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 If condition persists longer, consult a doctor This product is not effective on the scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Helianthus annuus flowering top, Vitis Vinifera Fruit Oil, Peppermint, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene.
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.Uses Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm) For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections Prevents most tinea pedis (athlete’s foot) with daily use.
Purpose
Information about the drug product’s indications for use.Purpose Topical Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Miconi-AL Miconazole Nitrate HELIANTHUS ANNUUS FLOWERING TOP VITIS VINIFERA FRUIT OIL PEPPERMINT .ALPHA.-TOCOPHEROL ACETATE BUTYLATED HYDROXYTOLUENE MICONAZOLE NITRATE MICONAZOLE
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.Product label image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information Protect the product in this container from excessive heat and direact sun
QUESTIONS? 602-887-9879
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.Warnings For external use only Do Not Use – On children under 2 years of age unless directed by a doctor. When using this product , avoid contact with eyes. Stop use and ask a doctor , if irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch) Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding , ask a health professional before use.
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