Label: TOPCARE ANTIFUNGAL MAXIMUM STRENGTH- 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 February 18, 2021

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

  • ​Active ingredient

    Undecylenic Acid 25%

  • ​Purpose

    Anti-fungal

  • Uses

    Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
    For effective relief of itching, burning and cracking.
  • Warnings

    For external use only

    Do not use

    on children 2 years of age unless directed by a doctor.

    When using this product

    avoid contact with eyes

    Stop use and consult a doctor if

    there is no improvement within 4 weeks
    irritation occurs

    KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

    If case of accidental ingestion, contact a physician, emergency medical care facility, or Poison Control Center immediately for advice at 1-800-222-1222.

  • ​Directions

    Read all warnings and directions. Use only as directed.

    clean the affected area with soap and warm water and dry thoroughly.
    Apply a thin layer of Anti-Fungal liquid solution over affected area twice daily (morning and night) or as directed by a doctor.
    The brush applicator allows for easy application under nails and surrounding cuticle area.
    wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    for athlete's foot: pay special attention to spaces between toes.
    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.
    Supervise children in the use of this product.
  • Other information

    Store at room temperature 15°-30°C (59° - 86°F).
    Protect from freezing. If freezing occurs warm to room temperature.
  • ​Inactive ingredient

    Isopropyl palmitate

  • Questions?

    Call 1-888-423-0139

  • Principal Display Panel

    NDC 36800-754-01

    COMPARE TO FUNGICURE® active ingredient*

    MAXIMUM STRENGTH
    Anti-Fungal Liquid

    Topical formula for toe and foot
    Stops most athlete’s foot fungus and ringworm
    Helps relieves related discomforts

    1 FL OZ (30mL)

    QUALITY GURANTEED

    This Top Care® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

    Side Panel

    How to Eliminate Fungus?

    Toe fungus can affect the areas around the cuticles and the skin around the tip of the nails. Anti-fungal work on contact but do not penetrate the nail,

    So make sure tom keep nails clipped and clean away flaky skin and nail keratin when treating affected areas.

    Anti-Fungal Liquid solution gets into hard to reach places, right where it’s needed, to treat fungus and stop it from spreading.

    When will you see results?

    Anti-Fungal Liquid begins working immediately to eliminate toe and athlete’s foot fungus.
    You should begin to see results in 4 weeks.
    You may need to continue treating to allow for regrowth of healthy new tissue.

    *This product is not manufactured or distributed by Alva-Amco Pharmacal Companies, the distributor of FungiCure®.

    DISTRIBUTED BY

    TOPCO ASSOCIATES LLC

    ELKGROVE VILLAGE, IL 60007

    © TOPCO RSE515

    QUESTIONS? 1-888-423-0139

    topcare@topco.com

    www.topcarebrand.com

    Anti- Fungal Liquid TopCare Maximum Strength 30 mL
  • INGREDIENTS AND APPEARANCE
    TOPCARE ANTIFUNGAL  MAXIMUM STRENGTH
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-754
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-754-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/22/2019
    Labeler - TOPCO ASSOCIATES LLC (006935977)