80% WITH DENATURANT AND FRAGRANCE- easy ecosave liquid 
Easy Energy Systems, Inc.

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.

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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

If contact with eyes, rinse thoroughly with clean water.

Stop use if irritation or rash appear.

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

Inactive ingredients

bitrex, distilled water, fragrance, glycerin, hydrogen peroxide

Package Label - Principal Display Panel

3785 ml image for 81184-005-05

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)

Revised: 7/2021
Document Id: c7845125-af05-1386-e053-2a95a90a92d8
Set id: b45619b4-56b0-2ae6-e053-2a95a90afea4
Version: 4
Effective Time: 20210719
 
Easy Energy Systems, Inc.