Label: BIOCARE LABS CLEAN HAND SANITIZER- ethyl alcohol 70% v/v 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 October 5, 2020

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  • DRUG FACTS

    Active Ingredient

    Ethyl Alcohol 70% v/v 

  • Uses:

    Hand Sanitizer to help decrease bacteria on the skin.

  • Warnings:

    For external use only.

    Flammable. Keep away from heat or flame.

    KEEP OUT OF REACH OF CHILDREN SECTION

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

  • Do not use:

    near or in the eyes. In case of contact, rinse eyes thoroughly with water.

  • WHEN USING

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if: if irritation or redness develop and lasts.

  • Directions:

    • Wet hands thoroughly with product.

    • Briskly rub hands together until dry.

    • Supervise children under the age of 6 when using this product

  • Inactive Ingredients:

    Deionized Water (Aqua, Eau), Glycerine, Melaleuca Alternafolia (Tea Tree) Leaf Oil,

    Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl
    Propanol, Acrylates Copolymer, Fragrance (Parfum), Polysorbate-20

  • Other Information:

    • Store at 20°C to 25 °C (68° – 77° F)
    • May discolor certain surfaces or fabrics.

  • For Questions:

    Biocare Labs © 2020 Chicago, IL 60469

    www.BiocareLabs.com

  • PRINCIPAL DISPLAY PANEL

    Clean Hand Sanitizer 2.0 FL OZ

  • PRINCIPAL DISPLAY PANEL

    Clean Hand Sanitizer Packet

  • INGREDIENTS AND APPEARANCE
    BIOCARE LABS CLEAN HAND SANITIZER 
    ethyl alcohol 70% v/v gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54602-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54602-100-000.060 L in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    2NDC:54602-100-010.0072 L in 1 BLISTER PACK; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2020
    Labeler - BIOCARE LABS INC. (798953493)
    Registrant - BIOCARE LABS INC. (798953493)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suraz Corporation Inc.050221596manufacture(54602-100)
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