Label: SINBIO SANITIZER S-300- didecyldimonium chloride and benzalkonium chloride liquid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 20, 2020

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  • DOSAGE & ADMINISTRATION SECTION

    Dosage and Administration Section79370-001-01

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredient Section79370-001-01

  • WARNINGS SECTION

    Warnings Section79370-001-01

  • INDICATIONS & USAGE SECTION

    Indications and Usage79370-001-01

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children79370-001-01

  • OTC - PURPOSE SECTION

    OTC - Purpose Section79370-001-01

  • OTC - ACTIVE INGREDIENT SECTION

    OTC - Active Ingredient79370-001-01

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    Label S-300 Sanitizer79370-001-01

  • INGREDIENTS AND APPEARANCE
    SINBIO SANITIZER S-300 
    didecyldimonium chloride and benzalkonium chloride liquid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79370-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18)0.32 mg  in 0.001 L
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 0.001 L
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDIMETHYLAMMONIUM CHLORIDE (UNII: VBX320461J)  
    BENZYLDIMETHYLOCTYLAMMONIUM CHLORIDE (UNII: OC19CZY82T)  
    WATER (UNII: 059QF0KO0R)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79370-001-015 L in 1 CONTAINER; Type 0: Not a Combination Product10/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2020
    Labeler - SINBIO, S.A. DE C.V. (951576424)
    Registrant - VR INTERNATIONAL LLC (074181935)
    Establishment
    NameAddressID/FEIBusiness Operations
    SINBIO, S.A. DE C.V.951576424pack(79370-001) , manufacture(79370-001) , label(79370-001)
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