Label: ALL-PURPOSE SANITIZER- alcohol liquid

  • 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 August 11, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin when water and soap are not available.

  • Warnings

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

    Do not use

    • Children under 6 years of age should be supervised when using this product
    • On open skin wounds

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

    Stop use and ask a doctor if irritation or rash occurs for more than 72 hours.

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

  • Directions

    • 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 or misuse.
  • Other information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients

    Glycerin, Hydrogen Peroxide, Purified Water USP.

  • Questions?

    1.888.613.4972   info@greengoohelps.com

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    Sierra Sage® Herbs LLC • 424 Main St. • Lyons, CO 80540 USA

  • PRINCIPAL DISPLAY PANEL - 499.79 ML Bottle Label

    GREEN GOO®

    KILLS 99.99%
    OF ILLNESS CAUSING GERMS

    ALL-PURPOSE
    SANITIZER

    FOR SURFACES + HANDS

    UNSCENTED - 16.9 FL. OZ. (499.79 ML.)

    PRINCIPAL DISPLAY PANEL - 499.79 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALL-PURPOSE SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-108-03499.79 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
    2NDC:77110-108-02946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/12/2020
    Labeler - Biominerales Pharma (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma117489663MANUFACTURE(77110-108)