Label: PURESKIN FUNGAL NAIL RENEWAL PATCHES patch

  • NDC Code(s): 83910-004-01
  • Packager: Xiamen Beishan Ecommerce Co.,LTD
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 9, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient

    Undecylenic Acid 8%

  • Purpose

    Antifungal

  • Use

    For repairing nails affected by fungal infections

  • Warnings

    1. Keep out of children's reach. Avoid contact with eyes, mouth, mucous membranes, wounds, or inflamed skin.
    2. External use only.
    3. Do not use if allergic to any ingredient.
    4. Do not use in children.
    5. Do not use if pouch is torn or broken.
    6. Discontinue use if skin becomes red, swollen, or itchy, and consult a healthcare professional.

  • Keep Oot Of Reach Of Children

  • Directions

    Begin by removing any nail polish. Cleanse nails and surrounding skin, ensuring thorough drying to enhance adhesion.
    a. Peel off protective films and sequentially.
    b. Apply the patch to the affected nail area, removing release paper.
    c. Firmly cover the sides of the toe or finger.
    d. Fold the remaining adhesive to envelop the toe/fingertip.
    e. Maintain the patch for 6-8 hours (overnight use recommended for 3-6 months).
    Use daily for optimal results. It is recommended to roughen the nail surface before application for better adhesion.

  • Other information

    Store at room temperature. Keep away from moisture and sunlight.
    Do not use if seal is broken or missing.

  • Inactive ingredients

    Polyester, Spandex, Acrylate Copolymer, Tackifying Resin, Glycerin, Water, Acrylic Copolymer, Silicone Oil, Paper

  • Questions

    info@pureskinsupport.com
    www.pureskinsupport.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PURESKIN FUNGAL NAIL RENEWAL PATCHES 
    pureskin fungal nail renewal patches patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83910-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID8 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    IVERMECTIN (UNII: 8883YP2R6D)  
    DICLORAN (UNII: F0BE9UC5J7)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ARCHANGELENONE (UNII: AG84U27TWU)  
    POLYESTER-7 (UNII: 0841698D2F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83910-004-0121 in 1 BOX; Type 0: Not a Combination Product09/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/30/2024
    Labeler - Xiamen Beishan Ecommerce Co.,LTD (707330558)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Beishan Ecommerce Co.,LTD707330558manufacture(83910-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!