Label: ACCALLO FUNGAL NAIL PATCHES- fungal nail patches patch

  • NDC Code(s): 82739-018-01
  • Packager: Shenzhen Situya Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 8, 2024

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

View All Sections
  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Anti-Fungal

  • Use

    Repairs fungal nail damage and improves nail appearance

  • Warnings

    For external use only.

  • Do not use

    ■ Do not use if you are allergic to any of the ingredients

    ■ Do not use if you are pregnant or breastfeeding

  • When Using

    ■ Avoid direct contact with eyes, mouth, mucous membrane, wounds

  • Stop Use

    ■ if irritation occurs and discomfort persists

  • Ask Doctor

    ■ if you have diabetes or poor blood circulation

  • Keep Oot Of Reach Of Children

    ■ In case of contact with eyes, flush with water for at least 15 minutes.
    ■ If swallowed, seek medical assistance immediately or contact a Poison Control Center.

  • Directions

    ■ Clean and thoroughly dry the affected area before application.

    ■ Peel off the patch's protective film, starting with the outer side and then the inner side.

    ■ Place the sticky side of the patch directly onto the infected area on the nail and remove the release paper.

    ■ Gently wrap the sides of the toe or finger to ensure a snug fit.

    ■ Fold the remaining adhesive part to cover the toe/fingertip.

    ■ Leave the patch on for 6–8 hours (It is recommended to use overnight for 3–6 months).

  • Other information

    ■ Store at room temperature and keep away from direct sunlight.
    ■ Skin discoloration may occur during or after use.

  • Inactive ingredients

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

  • Questions

    Accallo LLC
    1405 DEWAR DR. #1324
    ROCK SPRINGS, WY 82901
    Phone: 1-307-522-6324
    Email: info@accallo.com
    Website: www.accallo.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ACCALLO FUNGAL NAIL PATCHES 
    fungal nail patches patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82739-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    DICLORAN (UNII: F0BE9UC5J7)  
    POLYESTER-7 (UNII: 0841698D2F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82739-018-0132 in 1 BOX; Type 0: Not a Combination Product04/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/07/2024
    Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Situya Trading Co., Ltd.706154255manufacture(82739-018) , label(82739-018)
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!