Tolnaftate
FDA Label NDC 40002-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nexmed (usa), Inc. for the product Tolnaftate (NDC 40002-002). 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, 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 Ingredient

Tolnaftate

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete’s foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

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 2 weeks (for jock itch) and 4 weeks for (athlete’s foot and ringworm)

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

  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete’s foot, pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • For athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
  • If condition persists longer consult a doctor
  • This product is not effective on the scalp or nails

Other Information

  • Store between 20⁰ and 25⁰C (68⁰ to 77⁰F)
  • Lot No. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling

Inactive Ingredients

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Questions?

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

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