Label: ANTIBACTERIAL HAND SANITIZER- 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 January 4, 2022

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  • WARNINGS

    For external use only. Flammable. Keep away from het or flame. Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed, get medical help or contact a poison Control Center right away.

  • DO NOT USE

    Do not use on children less than 2 months of age. Do not use on open skin wounds.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Carbomer, Propylene Glycol, Triethanolamine, Aloe Barbadense Leaf Extract

  • PURPOSE

    Antiseptic

  • ACTIVE INGREDIENT

    Ethyl Alcohol 62%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STOP USE

    Stop use and ask doctor if redness or irritation develop and persist for more than 72 hours.

  • OTHER SAFETY INFORMATION

    Store at 20 C (68 to 77 F). May discolore fabrics.

  • Direction

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

  • Uses

    Hand Sanitizer to help decrease bacteria on the skin

  • PRINCIPAL DISPLAY PANEL

    70% Hand Sanitizer60 ml (2 oz). NDC 70445-415-20

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70445-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70445-415-2060 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2020
    Labeler - Webb Business Promotions, Inc (154445647)
    Registrant - Webb Business Promotions, Inc (154445647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Webb Business Promotions, Inc154445647manufacture(70445-415)
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