Hongo Killer Aerosol, Spray
FDA Label NDC 58593-625

Full FDA labeling including 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 58593-625). 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, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, indications & usage, 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

Miconazole Nitrate 2% W/W........................ Antifungal


Otc - Purpose


Uses
            Proven Clinically effective in the treatment of most:

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

    •              Relieves the following accompanying conditions:

    • 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, for diaper rash, near the eyesWhen using this product avoid contact with eyesStop 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
  • tinea pedis (athlete's foot) should be treated for 1 month to reduce the possibility of recurrence

    • Athlete's Foot and Ringworm - use daily for 4 weeks
    Jock Itch - use daily for 2 weeks
    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

Indications & Usage

Other information  store at room temperature 68-77 degrees F (20-25 degress C)

Otc - Questions

Questions or comments?


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

Inactive Ingredient

Inactive ingredients acetone, ethoxydiglycol, propylene glycol, SD alcohol 40-B (74% w/w), tocopheryl acetate

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