UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [HARMON STORE INC.]

UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [HARMON STORE INC.]
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NDC 63940-003-17
Set ID 404cd08d-d4bd-447e-a284-bc0499cbc0fb
Category HUMAN OTC DRUG LABEL
Packager Harmon Store Inc.
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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 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 15 0 - 30 0C (59 0 - 86 0F)
    • 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

    Harmon FaceValues

    MAXIMUM STRENGTH

    Toe & Foot ANTI-FUNGAL SOLUTION

    Undecylenic Acid

    PEN APPLICATOR

    Eliminates fungus on the fingers, toes and around nails

    • Pre-filled applicator pen brush
    • Convenient, easy use
    • Dries quickly
    • Non-oily, clear formula

    0.05 FL OZ (1.7mL)

    Har Anti-Fungal Pen Box_53-115HR.jpg

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-003
    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:63940-003-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product02/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/18/2014
    Labeler - Harmon Store Inc. (804085293)

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