Fungicure Soap
FDA Label NDC 52389-226

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kobayashi Healthcare International, Inc. for the product Fungicure (NDC 52389-226). 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, otc - ask doctor, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sepia 12x

Purpose

Antifungal treatment

Uses

For the treatment of most

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

    • For relief of:

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomforts which may accompany these conditions.

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use on children under 2 years of age.

Otc - When Using

When using this product avoid contact with the eyes.  If contact occurs rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot and tinea versicolor).

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.

Directions

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Clean the affected area with Fungicure Anti-Fungal Wash and warm water, rinse and dry thoroughly.
  • For best results, leave on for 1-2 minutes before rinsing and drying.
  • Use twice daily (morning and night), or as directed by a doctor.
  • This product is not effective on scalp or nails.
  • For jock itch, use daily for 2 weeks.
  • For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Intended for use by normally healthy adults only.
  • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
  • Supervise children in the use of this product.

Other Information

You may report serious side effects to the phone number provided under Questions? below.

Inactive Ingredients

Lauramidopropyl betaine, panthenol, phospholipid EFA, purified water, sodium chloride, sodium C14 - 16 olefin sulfonate, tea tree oil.

Otc - Questions

Questions?  1-800-792-2582

* Please review the disclaimer below.