Label: 80% WITH DENATURANT AND FRAGRANCE- easy ecosave liquid

  • NDC Code(s): 81184-005-03, 81184-005-05
  • Packager: Easy Energy Systems, Inc.
  • 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 July 19, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.
    5. Denaturant
    6. Fragrance
  • Active Ingredient(s)

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer helps reduce germs on the skin that may cause disease.

  • Warnings

    Flammable. Not for Human Consumption

    • External Use Only

    • Keep away from heat or flame

  • DO NOT USE

    • Do not use with children less than 2 months old
    • Do not use on open skin wounds
  • WHEN USING

    If contact with eyes, rinse thoroughly with clean water.

  • STOP USE

    Stop use if irritation or rash appear.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, Call Poison Control Center: 800 - 222 - 1222

  • Directions

    Apply a palmful of the product in cupped hand, covering all surfaces well with product.

    Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.

    Allow to dry without wiping.

    Prevent swallowing.

    Supervise children less than 6 years old.

  • Other information

    • Store between 59° F and 86° F
    • Avoid freezing and high heat (above 104° F)
  • Inactive ingredients

    bitrex, distilled water, fragrance, glycerin, hydrogen peroxide

  • Package Label - Principal Display Panel

    3785 ml image for 81184-005-05

  • INGREDIENTS AND APPEARANCE
    80% WITH DENATURANT AND FRAGRANCE 
    easy ecosave liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81184-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3028 mL  in 3785 mL
    Inactive Ingredients
    Ingredient NameStrength
    COUMARIN (UNII: A4VZ22K1WT) 17.94 mL  in 3785 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 54.9 mL  in 3785 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 4.73 mL  in 3785 mL
    WATER (UNII: 059QF0KO0R) 679 mL  in 3785 mL
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 15.1 mg  in 3785 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81184-005-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
    2NDC:81184-005-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2021
    Labeler - Easy Energy Systems, Inc. (789869885)
    Registrant - Easy Energy Systems, Inc. (789869885)
    Establishment
    NameAddressID/FEIBusiness Operations
    Easy Energy Systems, Inc.789869885manufacture(81184-005)