Label: ROYCEDERM TINEA VERSICOLOR RELIEF SOAP.- clotrimazole soap

  • NDC Code(s): 85261-311-01
  • Packager: Haikou Pucao Trading Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 2025

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  • ACTIVE INGREDIENT

    Coltrimazole 1%

  • PURPOSE

    Anti-fungal

  • INDICATIONS & USAGE

    Treats and prevents fungal infections including tinea versicolor, ringworm, athlete's foot, and jock itch.

  • WARNINGS

  • DO NOT USE

    For external use only. Do not use on children under two years of age unless directed by a physician.

  • STOP USE

    Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

  • KEEP OUT 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.

  • DOSAGE & ADMINISTRATION

    Apply to body and feet during shower or bath. Gently message over the entire body, focusing on affected areas. Rinse thoroughly with water. Use twice daily or as directed by a doctor.
    For best results use with RoyceDerm Tinea Treatment Cream.

  • OTHER SAFETY INFORMATION

    Store at room temperature and out of direct sunlight.

  • QUESTIONS

    Visit www.roycederm.com

  • INACTIVE INGREDIENT

    Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water, Lauric Acid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive) Fruit Oil, Sulfur, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Tinea packaging

  • INGREDIENTS AND APPEARANCE
    ROYCEDERM TINEA VERSICOLOR RELIEF SOAP. 
    clotrimazole soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85261-311
    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
    OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)  
    SORBITOL (UNII: 506T60A25R)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    SULFUR (UNII: 70FD1KFU70)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85261-311-01232 g in 1 CARTON; Type 0: Not a Combination Product03/25/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/25/2025
    Labeler - Haikou Pucao Trading Co.,Ltd (621948245)
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