FDA Label for Miconazole Nitrate Antifungal Powder
View Indications, Usage & Precautions
Miconazole Nitrate Antifungal Powder Product Label
The following document was submitted to the FDA by the labeler of this product Marlex Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Miconazole Nitrate 2%
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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