Active Ingredient(S)
Miconazole nitrate, USP 2%
Antifungal Cream
FDA Label NDC 21922-095
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Encube Ethicals, Inc. for the product Antifungal Cream (NDC 21922-095). 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(s), purpose, use(s), warnings, do not use, when using this product, stop use and ask doctor if, 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
Use(S)
■ proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
■ for effective relief of itching, scaling, cracking, burning, and discomfort
Warnings
For external use only
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 Doctor If
■ irritation occurs
■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 the spaces between the toes; wear well-filling, 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 lasts longer, contact a doctor
■ this product is not effective on the scalp or nails
Other Information
■ do not use if foil seal on tube opening is broken or missing
■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
■ store at room temperature 15°C to 30°C (59°F to 86°F)
■ before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients
benzoic acid, butylatyIated; hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7stearate, purified water
Questions Or Comments?
Call 1-833-285-4151
Principal Display Panel
Antifungal Cream
Miconazole Nitrate Cream, USP 2%
NET WT. 1.5 OZ (42.5 g)
Carton (42 5 Cart)
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