Label: BSAFE3 HAND SANITIZER- alcohol gel

  • NDC Code(s): 68957-2000-0, 68957-2000-1, 68957-2000-2, 68957-2000-3
  • Packager: Active Creations LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease 
    • recommended for repeated use
  • Warnings

    For external use only-hands

    Flammable. Keep away from heat and flame

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin 
    • do not inhale or ingest

    Stop use and ask a doctor if

    • irritation or redness develops 
    • condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, use under adult supervision
    • not recommended for infants
  • Other Information

    • do not store above 105°F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    Water (aqua), Carbomer, Glycerin, Aloe Barbadensis Leaf Juice, Sodium Hydroxide

  • Package Labeling: 68957-2000-0

    Label

  • Package Labeling:68957-2000-1

    Box

  • Package Labeling:68957-2000-2

    Box2

  • Package Labeling:68957-2000-3

    Box3

  • INGREDIENTS AND APPEARANCE
    BSAFE3 HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68957-2000
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68957-2000-0946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:68957-2000-159 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    3NDC:68957-2000-259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    4NDC:68957-2000-3236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/01/2020
    Labeler - Active Creations LLC (119119545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Active Creations LLC119119545manufacture(68957-2000)
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