Active Ingredient
Miconazole Nitrate 2%
Miconazole Nitrate Antifungal Powder
FDA Label NDC 10135-720
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals, Inc. for the product Miconazole Nitrate Antifungal Powder (NDC 10135-720). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- For the treatment of most superficial skin infections caused by yeast (candida albicans)
- Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Warnings
- For external use only
Do Not Use
- on children under 2 years of age unless directed by a doctor
- avoid contact with the eyes
- for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
- for jock itch - if irritation occurs or if there is no improvement within 2 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.
Directions
- Clean the affected area and dry thoroughly
- Apply a layer of power over affected area twice a day (morning and night) or as directed by a doctor
- Supervise children in the use of this product
- 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 the scalp or nails.
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
Other Information
- Protect from freezing. Avoid excessive heat.
- Do not use if package is damaged
Inactive Ingredients
Allantoin, Chloroxylenol, fragrance, Imidazolidinyl Urea, Microcrystalline Cellulose, Tricalcium Phosphate, Corn starch.
Manufactured For/ Distributed By:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 04/22 DV
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