FDA Label for Antifungal Cream
View Indications, Usage & Precautions
Antifungal Cream Product Label
The following document was submitted to the FDA by the labeler of this product Encube Ethicals Private Limited. 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.
Active Ingredient(S)
Miconazole nitrate, USP 2%
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)
* Please review the disclaimer below.
