UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [FAMILY DOLLAR SERVICES INC.]

UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [FAMILY DOLLAR SERVICES INC.]
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NDC 55319-055-17
Set ID 01a3eb23-bea8-474d-aaf8-aabd23574710
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services 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 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

    FAMILY WELLNESS

    MAXIMUM STRENGTH

    Anti- Fungal Nail Pen

    Undecylenic Acid 25%

    Eliminates Fungus on Fingers, Toes and Around Nails

    • Pre- fikllled with applicator brush
    • Covenient and Easy to use
    • Dries Quickly 
    • Non - oily, clean Formula
    0.05 FL. OZ (1.7 mL)

    Family Dollar_Family Wellness - Anti-Fungal Nail Solution Pen_53-091FD-01.jpg

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-055
    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:55319-055-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product12/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/15/2017
    Labeler - Family Dollar Services Inc. (024472631)

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