Fungisolve Tolnaftate Antifungal
FDA Label NDC 70242-107

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Fungisolve Tolnaftate Antifungal (NDC 70242-107). 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 ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, when using this product, 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

Active Ingredients

Tolnaftate 1%


Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)

can prevent recurrence of most athlete's foot

relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.

Warnings

For external use only

Do Not Use

  • children under 2 years of age unless directed by a doctor
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Stop Use And Ask A Doctor If

too much irritation occurs or irratation gets worse

When Using This Product

avoid contact with the eyes or mouth. If eye contacts occurs, rinse eyes thoroughtly with water.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • adults and children 12 years and over
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily morning and night
  • supervis 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 a day.

Other Information

store between 20 to 25 C (68 to 77)F

do not accept if safety seal is torn broken or missing.

Inactive Ingredients

Ceteareth-6, cety stearyl alcohol, methylparaben, mineral oil, PEG-20 cetyl/stearyl ether, propylene glycol, propylparaben, purified water, sodium m-bisulfite, stearyl alcohol.

Questions?

Call 305 2618762 M-F 9AM to 4PM Eastern Time

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