Nail Renovar Plus Liquid
FDA Label NDC 50405-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sohm, Inc for the product Nail Renovar Plus (NDC 50405-030). 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, stop use and ask a doctor if, directions, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Proven effective in the treatment of:

  • Athlete's foot (tinea pedis)
  • Jock itch (tinea cruris)
  • Ringworm (tinea corporis)

Warnings

  • For External use only.
  • Avoid contact with eyes.
  • Do not use on children under 2 years of age unless directed by a doctor.

Stop Use And Ask A Doctor If

  • Irritation occurs 
  • There is no improvement within 4 weeks for athlete's foot or ringworm.
  • There is no improvement within 2 weeks for jock itch.

Directions

  • Wash the affected are with soap and water, then dry thoroughly.
  • Apply a thin layer of product over the affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children during use.

    • For Athlete's foot: Use daily for 4 weeks.

    • Pay special attention to spaces between toes
    • Wear well-fitting, ventilated shoes
    • Change shoes and socks at least once daily

      • For ringworm:  Use daily for 4 weeks.

      For jock itch: Use daily for 2 weeks.

      • If condition persists longer, consult a doctor
      • Not effective on the scalp or nails.
      • Not for the treatment of infected fingernails or toenails 
      • Not effective against bacteria or viruses

Inactive Ingredient

Sweet Almond oil, Citronella oil, Lavender oil, Tea Tree Oil, Jojoba oil, Clove Bud Oil, Neem oil, Vitamin E (Tocopheryl Acetate)

Other Information

  • SHAKE WELL BEFORE USE
  • Store at room temperature 15°C -30 °C (59°-86°F)
  • Protect from freezing; if freezing occurs, warm to room temperature
  • Keep tightly closed when not in use

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