NDC 75318-0106 Cela No-clean Hypochlorous Acid Disinfectant

Hypochlorous Acid Disinfectant

NDC Product Code 75318-0106

NDC CODE: 75318-0106

Proprietary Name: Cela No-clean Hypochlorous Acid Disinfectant What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hypochlorous Acid Disinfectant What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 75318 - Shanghai Wanlay Environmental Protection Technology Co., Ltd.
    • 75318-0106 - Cela No-clean Hypochlorous Acid Disinfectant

NDC 75318-0106-2

Package Description: 4 DRUM in 1 BOX > 5 L in 1 DRUM (75318-0106-1)

NDC Product Information

Cela No-clean Hypochlorous Acid Disinfectant with NDC 75318-0106 is a a human over the counter drug product labeled by Shanghai Wanlay Environmental Protection Technology Co., Ltd.. The generic name of Cela No-clean Hypochlorous Acid Disinfectant is hypochlorous acid disinfectant. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Shanghai Wanlay Environmental Protection Technology Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Cela No-clean Hypochlorous Acid 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 555 mg/5L

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)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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.

Product Labeler Information

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

Labeler Name: Shanghai Wanlay Environmental Protection Technology Co., Ltd.
Labeler Code: 75318
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: 12-23-2020 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.

Cela No-clean Hypochlorous Acid Disinfectant Product Label Images

Cela No-clean Hypochlorous Acid 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 Ingredient(S)

Hypochlorous acid 111 mg/L. Purpose: Kill pyogenic coccus, intestinal pathogenic bacteria, pathogenic yeast, and common bacteria of hospital infection.

Purpose

It is suitable for surgical hand antisepsis, hygienic hand antisepsis, skin disinfection (including damaged skin), disinfection of mucous membrane, general subject surface disinfection and air disinfection.

Use

It is suitable for surgical hand antisepsis, hygienic hand antisepsis, skin disinfection (including damaged skin), disinfection of mucous membrane, general subject surface disinfection and air disinfection.

Warnings

External Use Only.Keep out of reach children.❶ Can’t mix with other product;❷ Keep out of the sunlight, store in cool dry place, sealed preservation;❸ Undrinkable water.

Do Not Use

  • On children less than 2 months of ageon open skin woundsmixing this product with other disinfectants

Otc - When Using

When using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.This product is for external use. It should not be taken orally.This product has a certain corrosive effect on metal objects other than stainless steel, and should be used with caution.When sterilizing articles containing more organic objects, they should be completely removed and then disinfected.Use with caution for those with sensitive skin.Do not mix this product with other disinfectants.

Otc - Stop Use

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

Other Information

Storage: place it in a normal temperature and light-shielded environment.

Directions

Contentexposure timeMethodshygienic hand antisepsis1minAfter washing hands, spray the product directly on both hands and rubsurgical hand antisepsis3minWash and dry hands, forearms and lower upper arms with soap solution, then spray with appropriate amount of disinfectant and rub until drydisinfection of skin and mucous membranes3minSpray, repeatedly wipe or soakgeneral subject surface disinfection3minspray, wipe or soak with the product directlyair disinfection30minspray with the product directly in the air with the dosage of 10ml/m3

Inactive Ingredients

Sodium chloride, Water

* Please review the disclaimer below.