Label: FUNGICURE ANTI-FUNGAL WASH- sepia soap

  • NDC Code(s): 52389-226-06
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 29, 2023

If you are a consumer or patient please visit this version.

  • 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

  • ASK DOCTOR

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

  • 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).
  • 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.

  • QUESTIONS

    Questions?  1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    FungicureWashPDP

  • INGREDIENTS AND APPEARANCE
    FUNGICURE   ANTI-FUNGAL WASH
    sepia soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-226-06177 mL in 1 TUBE; Type 0: Not a Combination Product03/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/07/2016
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)