UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [ARMY & AIR FORCE EXCHANGE SERVICE]

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UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [ARMY & AIR FORCE EXCHANGE SERVICE]
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NDC 55301-130-17
Set ID 962680f1-06ed-4067-9477-de27ebd69532
Category HUMAN OTC DRUG LABEL
Packager ARMY & AIR FORCE EXCHANGE SERVICE
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
    • discomfort which may accompany these conditions
    • soreness
  • 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 reach of children.

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

  • Directions

    Read all warning 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 affected area twice daily (morning and night) or as directed by the 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 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. If condition persists longer, consult a doctor.
    • this product is not effective on the scalp or nails
  • Other information

    • store at room temperature 150 - 300C (590 - 860F)
    • protect from freezing. if freezing occurs, warm to room temperature.
    • keep tightly closed when not in use
  • Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Exchange Select

    Anti- Fungal pen

    Undecylenic Acid 25%

    Maximum Strength

    Eliminates fungus on fingers, toes and around nails

    Pre-filled Applicator Pen Brush

    Dries quickly

    Non-oily, Clear Formula

    COnvenient and Easy to Use

    NET CONTENTS 0.05 FL. OZ (1.7 mL)

    Exchange Select_Antifungal Pen_53-115ES.jpg

    pen

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-130
    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:55301-130-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product12/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/27/2017
    Labeler - ARMY & AIR FORCE EXCHANGE SERVICE (001695568)
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