Label: ANTIFUNGAL PEN- undecylenic acid 25% liquid

  • NDC Code(s): 85210-001-01, 85210-001-02, 85210-001-03
  • Packager: XF Agencija Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2025

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  • Active ingredient

    Undecylenic Acid 25%

  • Purpose

    Antifungal

  • Uses

    For the treatment of athlete's foot, jock itch, and ringworm.

  • Warnings

    For external use only.

  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor.

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

    Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

  • 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 warnings and directions

    ■ Use only as directed
    ■ Clean the affected area with soap and water and dry thoroughly

    ■ Remove cap from pen

    ■ Twist the base of the pen, with brush pointing downward, until product dispenses

    ■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

    ■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

  • Other information

    ■ Store at 15°-30°C (59° - 86°F)
    ■ Keep cap on pen when not in use

  • Inactive Ingredients

    Aloe Vera Extract, Sweet Almond Oil, Jojoba Oil, Tea Tree Oil, Manuka Oil, Clove Bud Oil, Lavender Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Tocopheryl Acetate (Vitamin E).

  • NDC 85210-001-01 (01 Pen 3 mL)

    1 PEN WITH BLEED.jpg

  • NDC 85210-001-02 (03 Pens 9 mL)

    3 PENS WITH BLEED

  • NDC 85210-001-03 (06 Pens 18 mL)

    6 PENS WITH BLEED

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL PEN 
    undecylenic acid 25% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85210-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    CLOVE OIL (UNII: 578389D6D0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85210-001-011 in 1 CARTON01/28/2025
    13 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:85210-001-023 in 1 CARTON01/28/2025
    23 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:85210-001-036 in 1 CARTON01/28/2025
    33 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/28/2025
    Labeler - XF Agencija Limited (687239979)
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