Label: 1% KETOCONAZOLE ANTIFUNGAL TREATMENT- antifungal treatment ointment

  • NDC Code(s): 82372-012-01
  • Packager: Good Manager Holdings Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 19, 2024

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

  • Active Ingredient

    Ketoconazole 1%

  • Purpose

    Antifungal Ointment

  • Use

    1 Treat fungal skin infections such as athlete's foot, jock itch, ringworm, and seborrheic dermatitis.
    2. Relieves itching, scaling, and discomfort caused by these fungal infections.

  • Warnings

    For external use only.

  • Do not use

    1. on skin that is broken or inflamed
    2. if you are allergic to ingredients in this product

  • When Using

    1. Avoid contact with the eyes
    2. If the product gets into eyes, rinse thoroughly with water.

  • Stop Use

    1. if a rash appears or the condition worsens
    2. if the condition does not improve in 2-4 weeks.

  • Ask Doctor

    if you are pregnant or breastfeeding.

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years and over
    1. Apply to the affected area once or twice daily or as directed by a doctor.
    2. Wash the affected skin with soap and water and dry completely before applying.
    Children under 12 years old. Ask a doctor before use.

    Instructions:
    1 Clean and dry the affected area before applying the ointment.
    2. Apply a small amount of ointment to the affected area and rub in gently.
    3. Use daily for up to 4 weeks or as directed by a doctor.

  • Other information

    1. Store at 20°C to 25°C (68°F-77°F)
    2. See top panel for lot number and expiration date

  • Inactive ingredients

    Borneol, Sophora Flavescens, Root Cnidium Monnieri, Fruit Kochia, Scopana Pollen, Dictamnus Dasycarpus Root, Smilax Glabra Whole, Artemisia Extract, Tea Tree Oil

  • Questions

    support@tagridllc.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    1% KETOCONAZOLE ANTIFUNGAL TREATMENT 
    antifungal treatment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82372-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORNEOL (UNII: M89NIB437X)  
    WORMWOOD (UNII: F84709P2XV)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CNIDIUM OFFICINALE ROOT OIL (UNII: 18602BEQ40)  
    BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)  
    SMILAX GLABRA WHOLE (UNII: H51N91QNEB)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    SCOPINE (UNII: Z5LGM3Q28U)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82372-012-0120 g in 1 TUBE; Type 0: Not a Combination Product08/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/19/2024
    Labeler - Good Manager Holdings Inc (118382673)
    Establishment
    NameAddressID/FEIBusiness Operations
    Good Manager Holdings Inc118382673manufacture(82372-012)