Active Ingredient
Miconazole Nitrate USP 2.0%
Miconazole Cream
FDA Label NDC 87236-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Miconazole Cream (NDC 87236-013). 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, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- relieves itching, scaling, cracking, burning, discomfort and chafing associated with jock itching, burning feet irritation,
Warnings
For external use only
Do Not Use
- on children under 2 years of age unless directed by doctor
When Using This Product
- avoid contact with the eyes
Stop Use And Ask A Doctor
■ irritation oc:curs
■ 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 and ringworm
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)
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
■ 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
■ to open: unscrew cap, pull tab to remove foil seal
■ store at 20° to 25°C (68° to 77°F)
■preserve in tight container
■ see tube crimp for lot number and expiration 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, zinc oxide.
Questions?
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