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Product NDC Code | 0316-0225 | ||||||||||
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Drug Name | Desenex |
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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, 998465 |
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Application Number | M005 | ||||||||||
Labeler Name | Crown Laboratories | ||||||||||
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 and 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. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 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 1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, 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) Relieves itching, burning, cracking, and discomfort
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.Desenex MICONAZOLE NITRATE STARCH, TAPIOCA TRICALCIUM PHOSPHATE CAPRYLYL GLYCOL WATER STARCH, CORN 1,2-HEXANEDIOL ALOE VERA LEAF YEAST .BETA.-D-GLUCAN GLYCERIN POTASSIUM SORBATE MICONAZOLE NITRATE MICONAZOLE SODIUM BENZOATE
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 New & Improved Desenex® Antifungal Foot Powder with 2% Miconazole Nitrate PRESCRIPTION STRENGTH Cures Most Athlete's Foot Triple Action Powder Relieves Itching, Burning, and Scaling Attacks and Absorbs Moisture All Day Odor Control NET WT. 1.5 oz [43g] PRODUCT PACKAGED BY WEIGHT NOT VOLUME ©2023 Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc . Johnson City, TN 37604 DESENEX is a registered trademark of Crown Laboratories, Inc. P12319.00 Desenex Bottle Label
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. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-833-279-6522
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20 o - 25 o C (68 o - 77 o 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. Avoid contact with eyes. Do not use on children under 2 years of age unless directed by a doctor. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult 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