Drug class
Azole Antifungal [EPC]; Azoles [CS]
Uses
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
Warnings For external use only. Do not use if the safety-sealed tube is punctured or damaged. Do not use on children 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. Stop use and ask a doctor if Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). Irritation occurs, or if there is no improvement within 2 weeks (for jock itch). Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Contraindications
CONTRAINDICATIONS Patients known to be hypersensitive to this drug.
Overdose
OVERDOSAGE Overdosage of miconazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 578 . 1, greater than 640, 275 . 9 and greater than 160 mg/kg, respectively.
Dosage & administration
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 doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Active ingredient
Active ingredient Miconazole nitrate 2%
Inactive ingredient
Inactive ingredients 1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Lactobacillus Ferment, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch
Side effects
ADVERSE REACTIONS During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1 . 3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0 . 5% incidence. The therapy-related dropout rate was 0 . 3%. To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.