Label: PREMIER VALUE ANTIFUNGAL MAXIMUM STRENGTH- undecylenic acid liquid

  • NDC Code(s): 68016-474-00
  • Packager: PHARMACY VALUE ALLIANCE, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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

  • ​Active ingredient

    Undecylenic Acid 25%

  • ​Purpose

    Anti-fungal

  • Uses

    For the cure of most:
    ringworm (tinea corporis)
    athlete’s foot (tinea pedis)
    itching
    scaling
    cracking
    burning
    redness
    soreness
    irritation
    discomfort

    which may accompany these conditions.

  • Warnings

    For external use only

    Ask a 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
    there is no improvement within 4 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control right away at 1-800-222-1222.

  • ​Directions

    Read all warnings and directions.

    Read all package directions and warnings before use
    Use only as directed
    clean the affected area with soap and warm water and dry thoroughly
    Apply a thin layer of this product 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
    this product is not effective on the scalp or nails
    for athlete's foot: pay special attention to spaces between 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 conditions persists longer, consult a doctor
    Intended for use by normally healthy adults only
    Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor
    Supervise children in the use of this product
  • Other information

    This product may be applied to exposed nail-beds to cuticles, around nail edges and under nail tips where reachable with its applicator brush
    This product is not intended to, nor will it, penetrate hard nail surfaces
    While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use this product until satisfactory results are obtained.
    store at room temperature. Keep the container tightly closed when not in use.
    Store away from excessive heat and cold.
  • ​Inactive ingredient

    Isopropyl palmitate

  • Questions?

    Call 1-866-467-2748

  • Principal Display Panel

    NDC 68016-474-00

    COMPARE TO THE ACTIVE INGREDIENT FUNGICURE®

    MAXIMUM STRENGTH
    Anti-Fungal Liquid

    Topical formula for toe and foot
    Cures and Heals athlete’s foot fungus and ringworm
    Helps relieves related discomforts

    1 FL OZ (30mL)

    IMPORTANT: KEEP this carton for future reference on full labeling

    Distributed By:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    *This product is not manufactured or distributed by ALVA-AMCO Pharmacal Cos., Inc., the distributor of Fungi Cure®

    Premier Value Max Str Anti Fungal Liquid
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE ANTIFUNGAL  MAXIMUM STRENGTH
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-474
    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:68016-474-0030 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/10/2019
    Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)