Label: MICRO DEFENCE ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride 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 January 19, 2022

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT

    Inactive ingredients cocamidopropyl propylene glycol-dimonium chloride phosphate, water

  • QUESTIONS

    Questions? +1-305-985-7803
    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    • decreases bacteria on the skin
    • no water required
    • non drying

    Contains: Benzalkonium Chloride 0.1% w/v

    Manufactured by:

    Caronlab Australia Pty Ltd

    148-150 Victoria St,

    North Geelong, VIC, Australia 3215

    Product of Australia

    www.caronlab.com.au

    Phone: + 1-305-985-7803

    Made in Australia   Dispose of thoughtfully   Vegan friendly   Certified Cruelty Free

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MICRO DEFENCE ANTISEPTIC HAND SANITIZER FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77277-633
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77277-633-68200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/30/2020
    Labeler - CARONLAB AUSTRALIA PTY LTD (754402154)
    Establishment
    NameAddressID/FEIBusiness Operations
    CARONLAB AUSTRALIA PTY LTD754402154manufacture(77277-633)
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