Miconazole Nitrate 2% Cream Antifungal Cream
FDA Label NDC 0536-1375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby for the product Miconazole Nitrate 2% Cream Antifungal (NDC 0536-1375). 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 drug facts, active ingredient, purpose, otc - keep out of reach of children, uses, warnings, other information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Miconazole Nitrate 2%
Purpose
Anti-Fungal
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Uses
- proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Warnings
For external use only. Do not use if the safety-sealed tube is punctured or damaged.
Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes.
Stop use and ask a doctor if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).
Other Information
Distributed by:
Rugby Laboratories
Indianapolis, IN. 46268
800-616-2471
www.majorpharmaceuticals.com
This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.
• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.
Directions
Clean 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 healthcare professional • Supervise children in the use of this product.
For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.
For ringworm: Use daily for 4 weeks. If condition persists, consult a doctor.
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.
Inactive Ingredient
Inactive ingredientsCarbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, petrolatum.
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