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| Product NDC Code | 58980-819 | ||||
|---|---|---|---|---|---|
| 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 | LIQUID | ||||
| Application Number | M005 | ||||
| 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 Wash the affected area well with AZOLEN Anti-Fungal Wash and let product sit 1-2 minutes before rinsing Dry the affected area thoroughly Apply the product over the 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 For athlete's foot and 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 scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Lauramidopropyl Betaine, Laureth-7, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate, Tea Tree Oil.
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 For the treatment of most: athlete's foot jock itch ringworm Relieves: itching scaling cracking burning redness discomfort
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 SODIUM CHLORIDE PANTHENOL TEA TREE OIL LAURETH-7 SODIUM C14-16 OLEFIN SULFONATE LAURAMIDOPROPYL BETAINE LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE WATER
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 - 170 g Bottle Box NDC 58980-819-60 AZOLEN™ ANTI-FUNGAL WASH (MICONAZOLE NITRATE 2%) NOW TREAT JOCK ITCH IN THE SHOWER SOOTHES AND CONTROLS MOST:* JOCK ITCH ATHLETE'S FOOT RINGWORM STRATUS PHARMACEUTICALS INC Net Wt 6 oz (170 g) Principal Display Panel - 170 g Bottle Box
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
Distributed by: Stratus Pharmaceuticals Inc. Miami, FL 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 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 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 or Comments? Call us at 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.Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks (for jock itch) there is no improvement within 4 weeks (for athlete's foot and 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 eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled 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 unless directed by a doctor for diaper rash When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks (for jock itch) there is no improvement within 4 weeks (for athlete's foot and ringworm) Keep out of 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