Label: CARE AND CO HAND SANITIZER- benzalkonium chloride gel

  • 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 February 3, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only.

    Do not use

    in the eyes

    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.

  • Other information

    • Store between 59-86°F (15-30°C)
    • Avoid freezing and excessive heat above 104°F (40°C)
  • Inactive ingredients

    Glycerin, hydroxyethyl cellulose, reverse osmosis water.

  • Questions or Comments?

    (866) 322-7326

  • Package Labeling:59ml

    label

  • Package Labeling:237ml

    label2

  • Package Labeling:500ml

    label3

  • Package Labeling:1L

    label4

  • INGREDIENTS AND APPEARANCE
    CARE AND CO HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80755-000
    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
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80755-000-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    2NDC:80755-000-02237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    3NDC:80755-000-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    4NDC:80755-000-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/15/2020
    Labeler - CARE AND COMPANY USA. LLC (107409020)
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