NDC 78922-151 Disinfecting Wipes

Disinfecting Wipes

NDC Product Code 78922-151

NDC 78922-151-13

Package Description: 50 CLOTH in 1 BAG

NDC 78922-151-19

Package Description: 80 CLOTH in 1 BAG

NDC Product Information

Disinfecting Wipes with NDC 78922-151 is a a human over the counter drug product labeled by Henan Meishiyu Sanitary Products Co., Ltd. The generic name of Disinfecting Wipes is disinfecting wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Henan Meishiyu Sanitary Products Co., Ltd

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Disinfecting Wipes 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.

  • BENZALKONIUM CHLORIDE .9375 mg/1

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: Henan Meishiyu Sanitary Products Co., Ltd
Labeler Code: 78922
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-15-2020 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.

Disinfecting Wipes Product Label Images

Disinfecting Wipes 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

Benzalkonium chloride 0.025% v/v. Purpose: Antiseptic

Purpose

Antiseptic

When Using

When using this product keep out of eyes.In case of contact with eyes, rinse eyes throughly with water.

Do Not Use

In or contact the eyes

Stop Use

Discontinue if irritation and redness develop. If the condition persists for more than 72 hours, consult a physician.

Otc - Keep Out Of Reach Of Children

Keep this out of reach of children.If swallowed, get medical help immediately.

Indications & Usage

These wipes do not replace wipes used for medical procedures.Used for cleaning, disinfection and steriization in daily life.Cleaning and disinfection of object surfaces, especially hands and skin.

Directions

Uncover the seal on the package, take out the Wipes and directly wipe the object and skin surface directly.

Warnings

For external use only.These wipes do not replace wipes used for medical procedures.

Other Information

After use, please close the cover and keep it tight to prevent water loss.This product is insoluble in water. Please do not put it into the toilet after use.

Inactive Ingredient

Water

* Please review the disclaimer below.