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| Product NDC Code | 67091-392 | ||||
|---|---|---|---|---|---|
| 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 | 998428 | ||||
| Application Number | M005 | ||||
| Labeler Name | Winco Foods, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Miconozole 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 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 scalp or nails if nozzle clogs, clean with a pin
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch
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 (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris) relieves symtoms 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 Powder Spray ISOBUTANE ALCOHOL MICONAZOLE NITRATE MICONAZOLE DISTEARDIMONIUM HECTORITE ZEA MAYS SUBSP. MAYS WHOLE KAOLIN
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 Foot Powder Spray Miconazole Nitrate 2%/ ANTIFUNGAL Cures Most Athelete's Foot Relieves Itching, Cracking and Burning Talc Free NET WT 4.6 OZ (130g) miconazole 4
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on children under 2 years of age unless directed by a doctor.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other infomation store between 20 o and 30 o C (68 o and 86 o F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call 800-824-1706 Monday - Friday 9 am - 4pm MST
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 irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
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
Safe handling warning
Safe Handling WarningFlammable : Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrationg and inhaling contents can be harmful or fatal.
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. 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 120°F. Intentional misuse by deliberately concentrationg and inhaling contents can be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch Do not use on children under 2 years of age unless directed by a doctor. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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