Label: BIOZONE- alcohol 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 16, 2021

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  • ACTIVE INGREDIENT SECTION

    Active ingredient Ethyl Alcohol 70%

  • DOSAGE AND ADMINISTRATION SECTION

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • INACTIVE INGREDIENT SECTION

    Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

  • INDICATIONS AND USAGE SECTION

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Purpose Antmicrobial

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only. Flammable. Keep away from heat or flame

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • ASK A DOCTOR

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • PACKAGE LABEL SECTION

    HAND SANITIZER BIOZONE 60ml.jpgHAND SANITIZER BIOZONE 180ml.jpgHAND SANITIZER BIOZONE 250ml.jpgHAND SANITIZER BIOZONE 1000ml.jpgHAND SANITIZER BIOZONE 3780ml.jpg

  • INGREDIENTS AND APPEARANCE
    BIOZONE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78349-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
    TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78349-0003-160 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
    2NDC:78349-0003-2180 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
    3NDC:78349-0003-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
    4NDC:78349-0003-41000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
    5NDC:78349-0003-53780 mL in 1 JUG; Type 0: Not a Combination Product02/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/15/2021
    Labeler - Biozone Chemical, S. de R.L. de C.V. (812910867)
    Registrant - Biozone Chemical, S. de R.L. de C.V. (812910867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biozone Chemical, S. de R.L. de C.V.812910867manufacture(78349-0003)
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