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  5. Label Information: Fungicure Anti-fungal Wash

FDA Label for Fungicure Anti-fungal Wash

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fungicure Anti-fungal Wash Product Label

The following document was submitted to the FDA by the labeler of this product Alva-amco Pharmacal Companies, 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.

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.