Label: ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID- undecylenic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • Drug Facts

  • Active Ingredient

    Undecylenic Acid 25%

    Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
    • For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort
  • Warnings

    For external use only.

    Do not use 

    • on children under 2 years of age unless directed by a doctor.

    When using this product

    • avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs or if there is no improvement within 4 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. 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. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • Inactive ingredients

    Aloe Vera Extract, Canola Oil, Clove Bud Oil, Lavender Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond Oil, Tea Tree Oil, Tocopheryl Acetate

  • Package Labeling:

    Outer Package0Inner Package0

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83691-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CLOVE OIL (UNII: 578389D6D0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83691-000-001 in 1 BOX02/01/2023
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/01/2023
    Labeler - Sansar, LLC (127927811)
    Registrant - Fashion Pearlz, LLP (093638579)
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