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| Product NDC Code | 56104-141 | ||||
|---|---|---|---|---|---|
| Drug Name | Miconazole nitrate |
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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 | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 998533 | ||||
| Application Number | M005 | ||||
| Labeler Name | Premier Brands of America Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 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 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 conditions persist, 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 acetone, ethoxyglycol, propylene glycol, SD alcohol 40-B (74%w/w), tocopheryl acetate
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 cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris) relieves symptoms of athlete's foot, including itching burning and cracking
Purpose
Information about the drug product’s indications for use. Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Miconazole nitrate Antifungal Miconazole Liquid Continuous Spray ACETONE DIETHYLENE GLYCOL MONOETHYL ETHER PROPYLENE GLYCOL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE 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.Principal Display Panel Premier Medicated Antifungal Continuous Liquid Spray Miconazole Nitrate 2% Sprays At Any Angle! Cures and prevents most Athletes Foot Relieves itching and burning NET WT 5.3 FL OZ (150g) PB Antifngl Mic Contin LiqSpry label.jpg
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 20º and 30ºC (68ºF and 86º)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted. Questions? call 1-866-964-0939
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch irritation occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes or mouth use only as directed Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.
Safe handling warning
Safe Handling WarningExtremely flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate, contents under pressure. Do not store at temperature above 120ºF.
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. Extremely flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate, contents under pressure. Do not store at temperature above 120ºF. When using this product avoid contact with the eyes or mouth use only as directed Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal. Stop use and ask a doctor if no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.
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