Label: FUNGAL NAIL PATCHES- tolnaftate patch

  • NDC Code(s): 83364-011-01
  • Packager: YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 1, 2024

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  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Patch Drug Facts

    Active ingredients Purpose

    Tolnaftate 1.0%...........................................................................................................Anti-fungal

    Uses

    Repairs fungal nail damage and improves nail appearance

    For external use only

    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

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

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

  • INGREDIENTS AND APPEARANCE
    FUNGAL NAIL PATCHES 
    tolnaftate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-011
    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
    FUMARIC ACID (UNII: 88XHZ13131)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    UREA (UNII: 8W8T17847W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83364-011-0121 in 1 BOX09/24/2024
    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 other09/24/2024
    Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)
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