Label: MICROSURE HAND SANITIZER- benzalkonium chloride cloth

  • 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 December 9, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

    PURPOSE

    Antimicrobial

  • USES:

    Sanitizes hands to helps reduce bacteria that potentially cause diseases.

  • WARNINGS:

    For external use only.

    Do not use

    in eyes. If contact occurs, flush thoroughly with water.

    Stop use and ask a doctor:

    If irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children:

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

  • DIRECTIONS:

    Wipe on both hands to disinfect palms, between fingers, back of hands, and wrists. 8 hours of continues protection once skin is fully dry.

  • Inactive Ingredients:

    Water, Hydrated Silica Complex

  • Package Labeling:72513-001-00

    Label

  • INGREDIENTS AND APPEARANCE
    MICROSURE HAND SANITIZER 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72513-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72513-001-004 mL in 1 PATCH; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/20/2020
    Labeler - Strategia Project Management, Inc. (054047254)
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