Label: MAXIMUM STRENGTH ANTIFUNGAL NAIL LIQUID- undecylenic acid 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 November 16, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Undecylenic Acid 25% w/v

  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses  •treats most athletes foot (tinea pedis)

    and ringworm (tinea corporis).

  • WARNINGS

    Warnings

    For external use only.

    Ask doctor before use on children under 2 years

    of age.

    When using this product avoid contact with eyes.

    Stop use and consult a doctor if •irritation

    occurs  •   you do not notice improvement within 4

    weeks

  • BOXED WARNING (What is this?)

    DO NOT USE IF NECKBAND IS BROKEN

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of

    children. If accidental ingestion occurs,

    immediately contact a physician, emergency

    medical facility or a Poison Control Center for help.

  • DOSAGE & ADMINISTRATION

    Directions

    •using soap and water, clean the affected

    area, and dry thoroughly.

    •apply a thin layer of the product over affected

    area twice daily (morning and night) or as

    directed by a doctor.

    •use the brush applicator provided for easy

    application to the affected area.

    •for toe usage, change shoes and socks at least

    once daily and wear thin, well fitting, ventilated shoes.

    •pay particular attention to spaces between the toes

    for athletes foot.

    •for athletes foot and ringworm, use the product

    daily for 4 weeks. If condition persists longer,

    consult a physician.

    •this product is not effective on the scalp or nails.

    •children must be supervised in the use of

    this product.

  • STORAGE AND HANDLING

    Other information  •this product should be

    stored at room temperature 15º - 30° (59° - 86°F)

    •keep from freezing. If freezing occurs, warm to

    room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredient  isopropyl palmitate

  • QUESTIONS

    Questions?  Call 1-800-910-6874

    ​We welcome any questions

    you may have at Target.com/

    comments or -800-910-6874

  • DESCRIPTION

    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.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH  ANTIFUNGAL NAIL LIQUID
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-488
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID7.5 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-488-011 in 1 CARTON11/16/2017
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/16/2017
    Labeler - Target Corporation (006961700)