Hongo Killer Aerosol, Powder
FDA Label NDC 58593-285

9 label sections · Submitted to the FDA by Efficient Laboratories Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc for the product Hongo Killer (NDC 58593-285). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:             Purpose

Tolnaftate 1% W/W........................ Antifungal


Otc - Purpose

Purpose: Antifungal

Indications & Usage

Uses 

Proven clinically effective in the treatment of most:

  • athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)

    • Clinically proven to prevent most athlete's foot with dauly use

    Relieves 

    • itching
    • cracking
    • burning
    • scaling
    • discomfort

Warnings


Warnings

For external use only

Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees F. Use only as directed. intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or while smoking.


Otc - Do Not Use

Do not use on children under 2 years of age


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 or ringworm) or within 2 weeks (for jock itch)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • clean the affected area and dry thoroughly
  • shake can well before use: Hold can about 6 inches from the area to be treated.
  • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product

    • Athlete's Foot and Ringworm - use daily for 4 weeks

    Jock Itch - use daily for 2 weeks

    • to prevent most athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails

      • For athlete's foot:

      • pay special attention to the spaces between the toes
      • wear well-fitting, ventilated shoes, and change shoes and socks at least once a day

Otc - Questions

Questions or comments?


Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

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