Tolnaftate Cream
FDA Label NDC 68071-4245

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Tolnaftate (NDC 68071-4245). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Tolnaftate USP 1%

Purpose

Antifungal

Uses

  • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • 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

Otc - When Using

When using this product avoid contact with eyes

Stop Use And Ask A Doctor If

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

Keep This And All Drugs Out Of The Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the 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

    • use daily for 4 weeks. If condition persists longer, consult a doctor
    • pay special attention to the spaces between the toes
    • wear well fitting ventilated shoes
    • change shoes and socks at least once daily

      • For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

      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 at controlled room temperature 15°-30°C (59°-86°F)
  • Lot No. and Exp date: see crimp on tube or see box

Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic, White Petrolatum

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

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