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| Product NDC Code | 58980-818 | ||||
|---|---|---|---|---|---|
| Drug Name | Azolen |
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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 | TINCTURE | ||||
| RxCUI drug identifier | 998525 | ||||
| Application Number | part333C | ||||
| Labeler Name | Stratus Pharmaceuticals, Inc. | ||||
| Packages |
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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 Clean and dry the affected area. Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas. Supervise children in the use of this product. For athlete's foot and ringworm use daily for four (4) weeks. This product is not effective on scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Benzyl Alcohol, Glacial Acetic Acid, Isopropyl Alcohol, Laureth-4, Purified Water and Sodium Hydroxide Solution.
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) and ringworm (tinea corporis) For effective relief of itchy, scaly skin between the toes.
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.Azolen Miconazole Nitrate Miconazole Nitrate Miconazole Water Benzyl Alcohol Acetic Acid Isopropyl Alcohol Laureth-4 Sodium Hydroxide
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 - 29.57 mL Bottle Carton NDC 58980-818-10 AZOLEN ™ TINCTURE (MICONAZOLE NITRATE USP, 2%) TOPICAL ANTIFUNGAL Distributed by: STRATUS NET VOL.: 1.0 FL OZ (29.57 mL) Principal Display Panel - 29.57 mL Bottle Carton
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.Drug Facts
For more information, see enclosed package insert.
Distributed by: STRATUS PHARMACEUTICALS INC 12379 SW 130th Street Miami, Florida 33186
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 except under supervision of 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 the reach of children. If swallowed, get medical help or contact poison control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-442-7882
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.If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.
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.Avoid contact with eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.
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 except under supervision of doctor. Avoid contact with eyes. If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor. Keep out of the reach of children. If swallowed, get medical help or contact poison control center immediately.
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