Active Ingredient
Miconazole Nitrate USP 2%
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Antifungal (NDC 67777-710). 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, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole Nitrate USP 2%
Antifungal
• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruis), and ringworm (tinea corporis)
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, and itching, burning feet.
For External Use Only
• On children under 2 years of age unless directed by a doctor
• Avoid contact with eyes
• Irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor for athlete's foot and ringworm.
• Irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor for jock itch.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
• Clean the affected area and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
• 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.
• Store at controlled room temperature 20°-25°C (68°-77°F)
• Tamper evident. Do not use if seal is damaged.
cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, macrogol cetostearyl ether, propylene glycol, purified water, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, white petrolatum, zinc oxide
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