Active Ingredient
Tolnaftate 1%
Mentholatum Heel Revival Cream
FDA Label NDC 10742-0020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Mentholatum Heel Revival Cream (NDC 10742-0020). 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 if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Tolnaftate - Antifungal
Uses
- proven clinically effective in the treatment of most cracked heel athlete’s foot
- relieves cracking, irritation and discomfort
- prevents the recurrence of most cracked heel athlete's foot with daily use
- Clears up most athlete’s foot infection and with daily use helps keep it from coming back
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 A Doctor If
- irritation occurs
- there is no improvement within 4 weeks
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 areas between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- for athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor
- this product is not effective on the scalp or nails
Inactive Ingredients
water, caprylic/capric triglyceride, urea, cetyl alcohol, glycerin, glycine, hexadecane, tridecyl stearate, ethoxydiglycol, ceteth-23, polyacrylate crosspolymer-6, diethyl sebacate, dimethicone, hydroxyethylcellulose, lactic acid, phenoxyethanol, propylene glycol caprylate, simmondsia chinensis (jojoba) seed oil, sodium dilauramidoglutamide lysine, sorbitan stearate, squalane, zinc oxide
Questions?
1-877-636-2677 MON-FRI 9AM-5PM (EST)
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Central right away
Drug Facts
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