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  5. Label Information: Hongo Killer

FDA Label for Hongo Killer

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. INDICATIONS & USAGE
    8. OTC - QUESTIONS
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hongo Killer Product Label

The following document was submitted to the FDA by the labeler of this product Efficient Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients:             Purpose

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



Otc - Purpose




Uses

            Clinically proven to cure most:
  • athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)
    •             Clinically proven to prevent most athlete's foot from recurring
                 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
    • 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

Indications & Usage



Other information  store at room temperature


Otc - Questions



Questions or comments?


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


Inactive Ingredient



Inactive ingredients Alcohol SD-40-B (14% w/w), BHT, Isobutane (propellant), PPG-12-Buteth-16, talc


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