NDC 75430-001 Electrolyzed-oxidizing Water Disinfectant

Electrolyzed-oxidizing Water Disinfectant

NDC Product Code 75430-001

NDC 75430-001-01

Package Description: 30 mL in 1 BOTTLE

NDC 75430-001-02

Package Description: 50 mL in 1 BOTTLE

NDC 75430-001-03

Package Description: 80 mL in 1 BOTTLE

NDC 75430-001-04

Package Description: 100 mL in 1 BOTTLE

NDC 75430-001-05

Package Description: 120 mL in 1 BOTTLE

NDC 75430-001-06

Package Description: 150 mL in 1 BOTTLE

NDC 75430-001-07

Package Description: 300 mL in 1 BOTTLE

NDC 75430-001-08

Package Description: 500 mL in 1 BOTTLE

NDC 75430-001-09

Package Description: 2000 mL in 1 BOTTLE

NDC 75430-001-10

Package Description: 5000 mL in 1 BOTTLE

NDC 75430-001-11

Package Description: 10000 mL in 1 BOTTLE

NDC 75430-001-12

Package Description: 20000 mL in 1 BOTTLE

NDC 75430-001-13

Package Description: 30000 mL in 1 BOTTLE

NDC Product Information

Electrolyzed-oxidizing Water Disinfectant with NDC 75430-001 is a a human over the counter drug product labeled by Fuzhou Meimei Environmental Protection Technology Co., Ltd.. The generic name of Electrolyzed-oxidizing Water Disinfectant is electrolyzed-oxidizing water disinfectant. The product's dosage form is spray and is administered via topical form.

Labeler Name: Fuzhou Meimei Environmental Protection Technology Co., Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Electrolyzed-oxidizing Water Disinfectant Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYPOCHLOROUS ACID .9 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fuzhou Meimei Environmental Protection Technology Co., Ltd.
Labeler Code: 75430
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-06-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Electrolyzed-oxidizing Water Disinfectant Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingerdient

Available chlorine 0.9%

Purpose

Disinfect

Uses

High,medium and low level disinfection of medical devices and endoscopes;Skin and mucous membranes (Note:when used for mucosal disinfection,it is limited to medical and health institutions for diagnosis and treatment),wound disinfection;sanitary and surgical hand disinfection; genitalia and sexual health instruments disinfection;surface of hard objects,fabricsand other porous objects disinfection;drinking utensils, fruits and vegetables disinfection;Indoor air spray disinfection;

Warnings

Store in a cool,dry place; Avoid direct sunlight; Avoid eating by children, please keep out of reach of children; It is for external use only,not oral.

When Using Section

1.Use the original solution directly and do not mix it with other disinfectants.2.Organic substances may affect the sterilization efficiency of the product,and the disinfection effect is better after cleaning.

Directions

Spray,wipe,rinse, soak

Other Information

Physical indicators:Orp≥1100mv,ph value 2-3;Store between 15-30C(59-86F) ; Avoid freezing and excessive heat above 40C(104F)

Inactive Ingredients

Purified water

* Please review the disclaimer below.