Sanafitil Crema
FDA Label NDC 58988-1600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex Llc for the product Sanafitil Crema (NDC 58988-1600). 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, when using this product, stop use and ask a doctor if, do not use, 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

  • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevnet most athlete's foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings

For external use only

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

Do Not Use

on children under 2 years of age except under the advice and supervision of a doctor

Keep Out Of Reach Of Children

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

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)
  • this product is not effective on the scalp or nails

Inactive Ingredients

Carbomer, Cetyl alcohol, Chlorocresol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

* Please review the disclaimer below.