Label: CARE 2020 ADVANCED HAND SANITIZER- alcohol 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 July 9, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75 % v/v

    Purpose

    Antiseptic

  • Uses

    • For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.
  • Warnings

    For external use only

    Flammable. Keep away from heat or flame

    when using this product

    do not use in near eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor 

    if irritation or rash appears on the skin.

    Keep out of reach of children.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Children under 6 years of age should be supervised by adult when applying this product.
    • Do not use on children less than 2 months of age or on open skin wounds.
  • Other information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
    • May discolor some fabrics or surfaces
  • Inactive ingredients

    Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol.

  • Package Labeling:59ml

    Bottle

  • Package Labeling:100ml

    Bottle2

  • Package Labeling:300ml

    Bottle3

  • Package Labeling:500ml

    Bottle4

  • INGREDIENTS AND APPEARANCE
    CARE 2020 ADVANCED HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79189-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    INULIN (UNII: JOS53KRJ01)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79189-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    2NDC:79189-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    3NDC:79189-001-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    4NDC:79189-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/06/2020
    Labeler - Sassy Cosmetics, LLC (098254344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang iColor Biotech Co., Ltd554528308manufacture(79189-001)
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