Label: ANTI FUNGAL FOOT AND BODY- sepia officinalis juice,melaleuca alternifolia liquid

  • 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 June 5, 2024

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

  • Active ingredient                               Purpose

    SEPIA OFFICINALIS JUICE                   Antifungal treatment

    melaleuca alternifolia ( Tea                  Antifungal treatment
    Tree ) Leaf Oil

  • PURPOSE

  • 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
    ● irritation

  • Warnings

    For external use only

    Ask a doctor before use onchildren under 2 years of age.

    When using this productavoid 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.If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • DIRECTIONS

    • Read all package directions and warnings before use.
    • Use only as directed.
    • Clean the affected area with 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.
  • Inactive Ingredients

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

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI FUNGAL FOOT AND BODY 
    sepia officinalis juice,melaleuca alternifolia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83004-011
    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
    TEA TREE OIL (UNII: VIF565UC2G) (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL - UNII:VIF565UC2G) TEA TREE OIL0.04 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83004-011-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/30/2024
    Labeler - Rida LLC (004425803)