Label: UNDECYLENIC ACID- maximum strength antifungal pen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 20, 2016

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  • ​Active ingredient

    Undecylenic acid 25%w/w

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  • ​Purpose

    Antifungal

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  • Uses

    For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

    For relief of:

    • itching
    • burning
    • redness
    • irritation
    • scaling
    • soreness
    • discomfort which may accompany these conditions
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  • Warnings

    For external use only

    If pregnant or breastfeeding

    consult a healthcare professional before use.

    Do not use

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

    When using this product

    avoid contact with eyes

    Use only as directed

    by a doctor on persons with highly sensitive skin.

    Stop use and consult a doctor if

    • there is no improvement within 4 weeks
    • irritation occurs

    Keep out of children.

    If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

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  • ​Directions

    Read all warnings and directions. Use only as directed.

    • clean the affected area and dry thoroughly
    • twist pen base with 3 clicks to saturate brush
    • apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
    • the brush applicator allows for easy application under nails and surrounding cuticle area
    • supervise children in the use of this product
    • 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
    • for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor
    • this product is not effective on the scalp or nails
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  • Other information

    • store at room temperature 15°-30°C (59° - 86°F)
    • protect from freezing. If freezing occurs warm to room temperature
    • keep tightly closed when not in use
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  • ​Inactive ingredient

    isopropyl palmitate

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  • Questions?

    Call 1-866-910-6874

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  • Principal Display Panel

    Front Panel

    Compare to active ingredient in Fungi-Nail®* ​

    maximum strength
    antifungal pen
    25% undecylenic acid

    eliminates fungus on fingers, toes and around nails
    pre-filled applicator pen brush
    dries quickly
    non-oily, clear formula

    up & up
    1 count
     0.057 FL OZ (1.7mL)

    Side Panel

    maximum strength
    antifungal pen
    25% undecylenic acid

    This up & up​® ​antifungal pen eliminates and helps stop the spread of fungal infections on cuticles, around nail edges and under nail tips where reachable with applicator brush. Topical antifungal treatment will not penetrate hard nail surfaces.

    *This product is not manufactured or distributed by Kramer Laboratories, Inc., owner of the registered trademark Fungi-Nail​®. ​

    up&up Antifungal Pen box.jpgupup Antifungal Pen label.jpg

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  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    maximum strength antifungal pen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-260
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 25 mg  in 1.7 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-260-17 1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 04/01/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 04/01/2014
    Labeler - Target Corporation (006961700)
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