Label: FUNGIFREE FUNGAL NAIL PATCHES- tolnaftate patch

  • NDC Code(s): 83364-013-01
  • Packager: YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 14, 2024

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

View All Sections
  • DOSAGE & ADMINISTRATION

    Directions

    - Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months

  • OTHER SAFETY INFORMATION

    Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water

  • PRINCIPAL DISPLAY PANEL

    Drug Facts drug facts

    Active ingredients

    Tolnaftate 1.0%

    Anti-fungal

    Repairs fungal nail damage and improves nail appearance

    Do not use on children under 3 years of age unless directed by a doctor.

    When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water

    Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away

    Warnings

    For external use only

  • INGREDIENTS AND APPEARANCE
    FUNGIFREE FUNGAL NAIL PATCHES 
    tolnaftate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALUMINUM GLYCINATE (UNII: 1K713C615K)  
    CELLULOSE GUM (UNII: K679OBS311)  
    TARTARIC ACID (UNII: W4888I119H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    UREA (UNII: 8W8T17847W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83364-013-0121 in 1 PATCH10/21/2024
    10.7 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/21/2024
    Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)
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!