FDA Label for Miconazole Nitrate Cream 2%
View Indications, Usage & Precautions
Miconazole Nitrate Cream 2% Product Label
The following document was submitted to the FDA by the labeler of this product Ezricare Llc. 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
Antifungal
Uses
• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet
Warnings
For external use only
Do not use • on children under 2 years of age unless directed by a doctor • for diaper rash
When using this product • avoid contact with the eyes
Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm
Otc - Keep Out Of Reach Of Children
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 thin layer of cream 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
Other Information
• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients
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
Questions Or Comments?
718-502-6610 between 9 am to 4 pm EST, Monday-Friday.
Packaging
* Please review the disclaimer below.