Fungisolve Tolnaftate Antifungal
FDA Label NDC 70242-106

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 70242-106). 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, when using this product, stop use and ask a 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

Active Ingredients

Tolnaftate 1%


Purpose

Antifungal

Uses

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

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

Warnings

For external use only use only as directed

Do Not Use

  • children under 2 years of age unless directed by a doctor

When Using This Product

  • avoid contact with the eyes or mouth
  • use only as directed

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks (for athelete's foot and ringworm) or 2 weeks (for jock itch)

Keep Out Of Reach Of Children.

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

Directions

  • wash the affected area and dry thoroughtly
  • apply a thin layer over the affected area twice daily morning and night
  • supervice 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.
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if the condiotion persists longer, ask a doctor
  • this product is not effective on scalp or nails

Other Information

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

Tamper evident do not accept if safety seal is broken or missing.

Inactive Ingredients

Butylated hydroxyanisole, DMDM Hyantoin, Ethoxydiglycol, Eucaliptu oil, Glycerin, Methyl Sallicylate, Pepermint oil, Polyethylene Glycol, Propylen glycol.

Questions Or Comments?

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