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| Product NDC Code | 55681-165 | ||||
|---|---|---|---|---|---|
| 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 | POWDER | ||||
| RxCUI drug identifier | 998461 | ||||
| Application Number | M005 | ||||
| Labeler Name | TWIN MED, LLC | ||||
| 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 Ingredients 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 & dry thoroughly apply a thin layer of the product 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, & change shoes & socks at least once daily for athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 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 Colloidal Anhyhdrous Silica, Talcum Powder
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 fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet
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 SILICON DIOXIDE TALC 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.Pincipal Display Panel Principal Display and Drug Fact Panel
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 ■For diaper rash
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 information Store at room temperature
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 ■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm
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
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 ■For diaper rash When using this product avoid contact with the eyes Stop use and ask a doctor if ■Irritation occurs ■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm 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