Label: FUNGICURE FOR JOCK ITCH- sepia officinalis juice soap 

  • Label RSS
  • NDC Code(s): 52389-126-01, 52389-126-06
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/11

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

  • Active ingredient

    Sepia 12x

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  • Purpose

    Antifungal treatment

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  • Uses

    For the treatment of most

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

    For relief of:

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

    For external use only

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  • ASK DOCTOR

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

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  • WHEN USING

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

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  • Stop use and ask a doctor if

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

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  • Directions

    • Read all package directions and warnings before using.
    • Use only as directed.
    • Clean the affected area with Fungicure Anti-Fungal Soap for Jock Itch and Ringworm 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.
    • For jock itch, use daily for 2 weeks.
    • For ringworm and athlete's foot, use daily for 4 weeks.
    • 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.
    • Supervise children in the use of this product.
    • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
    • This product is not effective on the scalp or nails.
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  • Other information

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

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  • Inactive ingredients

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

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • PATIENT PACKAGE INSERT

    FUNGICURE Anti-Fungal Soap for Jock Itch and Ringworm

    Now Treat Jock Itch and Ringworm Infections in the Shower!

    Eliminates Common Fungus That Can Attack Healthy Skin.

    A WORD ABOUT FUNGICURE ANTI-FUNGAL SOAP FOR JOCK ITCH AND RINGWORM:

    FUNGICURE Anti-Fungal Soap for Jock Itch and Ringworm provides a convenient way to treat most jock itch, ringworm, athlete's foot and other common fungus infections of the body, hands and feet while you bathe or shower. Use FUNGICURE Anti-Fungal Soap for Jock Itch and Ringworm as you would any other liquid soap, but with the added confidence that it is also effective for eliminating/washing away fungus. Use FUNGICURE Anti-Fungal Soap for Jock Itch and Ringworm alone or with other methods you may be using to control fungal infections.

    WHAT IS FUNGUS INFECTION OF THE BODY, GROIN, AND HANDS and FEET AREAS?

    Generally speaking, common fungus infections of the body, hands and feet areas (topical infections) are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which exist in varying degrees, at all times in nature, and tend to thrive in dark, damp and moist conditions...in the soil...on animals as well as humans. These organisms may penetrate the skin's surface through even the smallest crack or tear, may be spread from animals to humans and may be spread among humans. Common topical fungus infections generally fall into three categories: microsporum (hair and skin), epidermophyton (skin and nails), and trichophyton (hair, skin and nails). Among the more common fungi are T. rubrum which can cause jock itch, E. floccosum which can cause ringworm infection and affects the body, hands and feet, on and in between the fingers including the skin around the fingernails; also T. rubrum and T. mentagrophytes, which can cause athlete's foot and infect the feet, on and between the toes including the skin around the toenails. Often such infections develop slowly and may be difficult to treat if not attended to promptly and treated appropriately with an effective anti-fungal medicine.

    HOW DO YOU KNOW IF YOU HAVE A TOPICAL FUNGUS INFECTION?

    Topical fungal infections can affect anyone, but men typically experience a higher incidence of jock itch than women. The appearance of jock itch can be characterized as:

    • A circular, reddish-brown, raised rash with elevated edges in the groin and/or thigh area.
    • Itching, chafing, burning or skin redness.
    • Flaking, peeling or cracking skin.
    Some topical fungus infections may present themselves on the skin as ring-like formations with clear centers, commonly referred to as ringworm. Other such infections, when on the feet, or finger and toe areas, are often characterized by scaling of the skin, burning, cracking, itching and related discomforts. When nails become infected, they may appear to become opaque (cloudy white), thickened, brittle, friable (easily broken) and in some cases, discolored (greenish/brown).

    WHAT ARE CAUSES OF JOCK ITCH, RINGWORM AND OTHER FUNGAL INFECTIONS?

    Jock itch and ringworm, like other fungal infections, can develop under a variety of conditions, including:

    • Hot and humid weather conditions that can cause perspiration to accumulate.
    • Friction caused by wearing tight, damp or perspiration-soaked clothing for an extended period of time (e.g. exercise or bathing suit garments).
    • Sharing clothes or towels with others who have a fungal infection.
    PRODUCT DESCRIPTION AND ACTION:

    FUNGICURE Anti-Fungal Soap for Jock Itch is an effective homeopathic formulation containing the ACTIVE INGREDIENT: Sepia 12x

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

    PROMPT ACTION AND PROPER TREATMENT:

    Recognizing and treating fungus infection early is very important for successful results, so it is wise to consult your doctor promptly for advice if you suspect you may have a fungal infection.

    HOW TO AVOID RECURRENCE OF FUNGUS INFECTION:

    • Good personal hygiene is your first line of defense against recurring fungus infections.
    • Shower or bathe daily, as well as after physical activity that may cause sweating.
    • Avoid sharing towels.
    • Change and wear clean clothing, especially undergarments that are in contact with affected areas, daily.
    • Avoid any practices that can tear or bruise skin. Anything that tears or opens the skin invites fungus to invade.
    • If you have a fungal infection on another area of your body, such as ringworm, athlete's foot,or finger and toe area fungus, be sure to treat it right away to help prevent the fungus from spreading to the groin area.

    Regular use of FUNGICURE Anti-Fungal Soap for Jock Itch helps eliminate/wash away fungus and bacteria that can attack healthy skin.

    Uses: For the treatment of most: jock itch (tinea cruris), ringworm (tinea corporis), athiete's foot (tinea pedis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts which may accompany these conditions.

    Warnings: For external use only.

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

    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 or there is no improvement within 2 weeks (4 weeks for ringworm and athlete's foot).

    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 using. Use only as directed. Clean the affected area with Fungicure Anti-Fungal Soap for Jock Itch and Ringworm 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. For jock itch, use daily for 2 weeks. For ringworm and athlete's foot, use daily for 4 weeks. For athlete's foot: pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Supervise children in the use of this product. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. This product is not effective on the scalp or nails.

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

    Questions? 1-800-792-2582

    How Supplied:
    6 fluid ounces (177 ml) bottle

    Storage:
    Keep tightly closed when not in use. Store away from excessive heat or cold. Close
  • INGREDIENTS AND APPEARANCE
    FUNGICURE  FOR JOCK ITCH
    sepia soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-126
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Lauramidopropyl betaine  
    Panthenol  
    Lecithin, soybean  
    Water  
    Sodium chloride  
    Sodium C14-16 olefin sulfonate  
    TEA TREE OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-126-06 1 in 1 CARTON
    1 NDC:52389-126-01 177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/23/2006
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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