Label: HAND CLEANSING GEL- hand sanitizer llc 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 April 23, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Hand Cleanser to help reduce bacteria on the skin.

  • WARNINGS

    Flammable, Keep away from fire or flame.

    For External use only

    When using this product do not use in or near the eys. In case of contact, rinse eyes intensely with water.

  • STOP USE

    Stop Use and ask a doctor if irritation or rash occurs and remains.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Put enough product in your palm to cover hands well and rub hands together until dry. Children under 6 years old should be supervised when using.

  • OTHER SAFETY INFORMATION

    Store under 110°F (43°C)

  • INACTIVE INGREDIENT

    Water (Aqua), Hydroxypropyl Cellulose, Glycerin, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Drug Facts 70% Alcohol Cleansing Gel

  • INGREDIENTS AND APPEARANCE
    HAND CLEANSING GEL 
    hand sanitizer llc gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76701-700
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76701-700-1717 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
    2NDC:76701-700-022 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
    3NDC:76701-700-088 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
    4NDC:76701-700-3232 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/16/2020
    Labeler - Hand Sanitizer LLC (117473019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hand Sanitizer LLC117473019pack(76701-700) , label(76701-700) , manufacture(76701-700)
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