EKO DISINFECTANT- hypochlorous acid liquid

EKO Disinfectant by

Drug Labeling and Warnings

EKO Disinfectant by is a Otc medication manufactured, distributed, or labeled by Heming (Shanghai) Environmental Technology Co., Ltd.. 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. HYPOCHLOROUS ACID (0.02%) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

HYPOCHLOROUS ACID 0.02 %

Purpose

Disinfectant.

Use

This product is suitable for disinfection of tableware, food processing tools and equipment, fruits and vegestables, hands and indoor air.

Warnings

For external use only. Do not mix with other alkaline or strong acid preparations.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

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.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• Please keep away from direct sunlight and high temperature and keep in a cool place

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

30ml NDC: 77756-001-01

INGREDIENTS AND APPEARANCE

EKO DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77756-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	200 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77756-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77756-001-03	98 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 77756-001-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 77756-001-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 77756-001-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 77756-001-08	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 77756-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 77756-001-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 77756-001-09	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 77756-001-10	25000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 77756-001-11	1000000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - Heming (Shanghai) Environmental Technology Co., Ltd. (554533962)

Establishment
Name	Address	ID/FEI	Business Operations
Heming (Shanghai) Environmental Technology Co., Ltd.		554533962	manufacture(77756-001)