NDC 77125-003 Wet Wipes Antibacterial Hand Wipes

Benzethonium Chloride

NDC Product Code 77125-003

NDC CODE: 77125-003

Proprietary Name: Wet Wipes Antibacterial Hand Wipes 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: Benzethonium Chloride 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

  • 77125 - Ningbo yinzhou Greenlight international trade Co.,ltd
    • 77125-003 - Wet Wipes Antibacterial Hand Wipes

NDC 77125-003-01

Package Description: 150 g in 1 BAG

NDC Product Information

Wet Wipes Antibacterial Hand Wipes with NDC 77125-003 is a a human over the counter drug product labeled by Ningbo yinzhou Greenlight international trade Co.,ltd. The generic name of Wet Wipes Antibacterial Hand Wipes is benzethonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Ningbo yinzhou Greenlight international trade Co.,ltd

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Wet Wipes Antibacterial Hand 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.

  • BENZETHONIUM CHLORIDE .45 g/150g

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Ningbo yinzhou Greenlight international trade Co.,ltd
Labeler Code: 77125
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: 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.

Wet Wipes Antibacterial Hand Wipes Product Label Images

Wet Wipes Antibacterial Hand 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

Active IngredientBenzethonium Chloride 0.3%

Purpose

Purpose Antimicrobial

Use

UseDecrease bacteria on skin

Warnings

For External use only

Do Not Use

Do not use if you are allergic to any of the ingredients

When Using This Product

​When using this product do not get into eyes, if contact occurs rinse thoughly with water

Stop Use And Ask A Doctor

Stop use and ask a doctor if irritation or rash develops and continues for more then 72 hours

Keep Out Of Reach Of Children

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center

Directions

  • DirectionsAdults and children 2 years and overapply to handsallow to dry without wiping Children under 2 years ask a doctor before use

Other Information

  • Other informationstore at room temperaturemay discolor certain fabrics

Inactive Ingredients

Inactive Ingredientswater, propylene gylcol, gylcerin, PEG-40 hydrogenated castor oil, disodium EDTA, aloe barbadnsis leaf juice, methylparaben, propylparaben

Package Label

32 wipes NDC 77125-003-01

* Please review the disclaimer below.