80% WITH DENATURANT AND FRAGRANCE- easy ecosave liquid

80% with Denaturant and Fragrance by

Drug Labeling and Warnings

80% with Denaturant and Fragrance by is a Otc medication manufactured, distributed, or labeled by Easy Energy Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

80% WITH DENATURANT AND FRAGRANCE 
easy ecosave liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81184-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3028 mL  in 3785 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81184-005-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
2	NDC: 81184-005-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2021

Labeler - Easy Energy Systems, Inc. (789869885)

Registrant - Easy Energy Systems, Inc. (789869885)

Establishment
Name	Address	ID/FEI	Business Operations
Easy Energy Systems, Inc.		789869885	manufacture(81184-005)