FDA Label for Miconazole Nitrate 2% Cream Antifungal
View Indications, Usage & Precautions
Miconazole Nitrate 2% Cream Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Rugby. 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.
Drug Facts
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.
* Please review the disclaimer below.