UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [CHAIN DRUG MARKETING ASSOCIATION]

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UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-120-17
Set ID 55833497-b3ef-47bd-8d91-d991aa5272c1
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number PART333C
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  • Active ingredient

    Undecylenic acid 25%w/w

  • Purpose

    Antifungal

  • Uses​

    For the 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
  • 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.

  • 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
    • 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
  • ​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
  • Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-248-449-9300

  • Principal Display Panel

    QC

    Quality Choice

    Maximum Strength

    ​Antifungal Pen

    ​Fungus Treatment

    ​25% Undecylenic Acid​

    Eliminates Fungus on Fingers, Toes and Around Nails

    Pre-Filled Pen with Brush Applicator

    Convenient & Easy to Use

    Dries Quickly

    Non-Oily, Clear Formula

    .05 FL OZ (1.7 mL)

    QC Antifungal Pen Box.jpg

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 1.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-120-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/01/2015
    Labeler - Chain Drug Marketing Association (011920774)
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