Label: ADVANCED- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 September 17, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Ethyl Alcohol 80% v/v............................................................................................................................................................. Antimicrobial

  • INACTIVE INGREDIENT

    Hand Sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    Flammable. Keep away from heat or flame.

    For external use only.

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

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • DOSAGE & ADMINISTRATION

    • Place enough product in your palm to cover hands and rub hands together until dry.
    • Children under 6 years of age should be supervised when using hand sanitizer.
  • OTHER SAFETY INFORMATION

    Store below 110 oF (43 oC)

    May discolor certain fabrics or surfaces

  • INACTIVE INGREDIENT

    Water (Aqua), Tert-butanol, Polyacrylate, Aminomethyl Propanol

  • INDICATIONS & USAGE

    For external use only

  • 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

    Hand Sanitizer to help reduce bacteria on the skin.

  • PRINCIPAL DISPLAY PANEL

    Advanced Hand Sanitizer Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77809-070
    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
    WATER (UNII: 059QF0KO0R) 29.23 mL  in 100 mL
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
    POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U) 0.4 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77809-070-017560 mL in 1 JUG; Type 0: Not a Combination Product09/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/25/2020
    Labeler - MFG Chemical, LLC. (066924424)
    Registrant - MFG Chemical, LLC. (066924424)
    Establishment
    NameAddressID/FEIBusiness Operations
    MFG Chemical, LLC.789380354manufacture(77809-070)
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