Active Ingredient
Tolnaftate 1%
Cr-371059 Tolnaftate 1% Cream
FDA Label NDC 50090-6147
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Cr-371059 Tolnaftate 1% (NDC 50090-6147). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• Helps prevent most athlete's foot with daily use
• For effective relief of itching, burning, and cracking
Warnings
• For External Use Only
• This product is not effective on the scalp or nails
When Using This Product
Avoid contact with the eyes
Stop Use And Ask A Doctor If
• Irritation occurs
• There is no improvement within 4 weeks
Keep Out Of Reach Of Children
• If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away
• Do not use on children under 2 years of age except under the advice and supervision of a doctor
Directions
• Wash affected area and dry thoroughly
• Apply a thin layer over affected area twice daily (morning and night)
• 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
• Use daily for 4 weeks; if condition persists longer, ask a doctor
• To prevent athlete's foot, apply once or twice daily (morning and/or night)
Other Information
Store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)
Questions And Comments?
1-800-645-2158
How Supplied
Product: 50090-6147
NDC: 50090-6147-0 1 g in a BOX
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