FUNGICURE ANTI-FUNGAL WASH (SEPIA) SOAP [DENISON PHARMACEUTICALS, LLC.]

FUNGICURE ANTI-FUNGAL WASH (SEPIA) SOAP [DENISON PHARMACEUTICALS, LLC.]
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NDC 0295-2600-23
Set ID a438c163-2175-4937-94ed-0064b540b91c
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC.
Generic Name
Product Class
Product Number
Application Number
  • 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

    Fungicure Soap

  • INGREDIENTS AND APPEARANCE
    FUNGICURE  ANTI-FUNGAL WASH
    sepia soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-2600
    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:0295-2600-23177 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2017
    Labeler - Denison Pharmaceuticals, LLC. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC.001207208manufacture(0295-2600)

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