Label: DERMAFOAM PREMIUM ANTIBACTERIAL- benzalkonium chloride soap

  • NDC Code(s): 53125-709-39
  • Packager: Superior Chemical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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  • ACTIVE INGREDIENT

    ​Active Ingredient

    ​ ​Triclosan 0.30%

  • INDICATIONS & USAGE

    Uses

    • ​​Antibacterial hand cleaner.
    • Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
  • WARNINGS

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • DOSAGE & ADMINISTRATION

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 0.8 mL of product onto wet palm.
    • Rub hands together to distribute product, then rinse hands with clean.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    ​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

  • QUESTIONS

    Questions or Comments?Phone: (800) 777-9343

    MDS information:​(800) 891-4965

  • PURPOSE

    Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    75129 Derma Foam 75129-00_Derma Foam Premium Antibacterial

  • INGREDIENTS AND APPEARANCE
    DERMAFOAM PREMIUM ANTIBACTERIAL 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53125-709
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53125-709-391000 mL in 1 BAG; Type 0: Not a Combination Product11/12/201201/01/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/12/201201/01/2030
    Labeler - Superior Chemical Corporation (023335086)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.005050158label(53125-709) , manufacture(53125-709)
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