Label: ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP.- antifungal soap soap

  • NDC Code(s): 82739-019-01
  • Packager: Shenzhen Situya Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 17, 2024

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

  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Anti-Fungal

  • Use

    Relieves and helps prevent recurrence of fungal skin infections including acne, jock itch, athlete's foot, ringworm, and tinea.

  • Warnings

    For external use only.

  • Do not use

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

  • When Using

    When using this product avoid contact with eyes.
    If contact occurs, rinse the eyes thoroughly with water.

  • Stop Use

    stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

  • Ask Doctor

    Ask a doctor before use if you are allergic to ingredients in this product

  • Keep Oot Of Reach Of Children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Apply to body and feet during shower or bath. Gently massage over the entire body, focusing on areas where odor or skin irritation is a concern. After gently washing, Rinse and dry skin and feet thoroughly.

  • Other information

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

  • Inactive ingredients

    Tea Tree Essential Oil, AQUA, Sorbitol, Palm Oil, Coconut Oil Extract, Olive Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate Glutamate, Sodium Hydroxide , Sodium Dodecyl Benzene Sulfonate, Sulfur Spring Extract, Witch Hazel, Ceramide

  • Questions

    Questions or comments?
    Visit www.roycederm.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP. 
    antifungal soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82739-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PALM OIL (UNII: 5QUO05548Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    SODIUM MYRISTATE (UNII: 06BLC4V0IV)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    SULFUR (UNII: 70FD1KFU70)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    SORBITOL (UNII: 506T60A25R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82739-019-012 in 1 BOX06/17/2024
    1116 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/17/2024
    Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Situya Trading Co., Ltd.706154255label(82739-019) , manufacture(82739-019)