NDC 76635-121 Julep Antibacterial Sanitizing Wipe

Benzalkonium Chloride

NDC Product Code 76635-121

NDC CODE: 76635-121

Proprietary Name: Julep Antibacterial Sanitizing Wipe 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: Benzalkonium 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

  • 76635 - Hangzhou Glamcos Biotech Co.,ltd
    • 76635-121 - Julep Antibacterial Sanitizing Wipe

NDC 76635-121-01

Package Description: 3.24 g in 1 BAG

NDC Product Information

Julep Antibacterial Sanitizing Wipe with NDC 76635-121 is a a human over the counter drug product labeled by Hangzhou Glamcos Biotech Co.,ltd. The generic name of Julep Antibacterial Sanitizing Wipe is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Hangzhou Glamcos Biotech 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.

Julep Antibacterial Sanitizing Wipe 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 .2 g/100g

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.

  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • SAMBUCUS NIGRA SEED OIL (UNII: ZZV3NWA4A3)
  • ECHINACEA PURPUREA (UNII: QI7G114Y98)

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: Hangzhou Glamcos Biotech Co.,ltd
Labeler Code: 76635
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: 09-23-2020 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.

Julep Antibacterial Sanitizing Wipe Product Label Images

Julep Antibacterial Sanitizing Wipe 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 0.2%

Purpose

Antibacterial

Use

For hand and surface sanitization, decrease amount of bacteria.

Warnings

For External Use Only.

Do Not Use on children less than 2 years of age.

On open wounds/cuts.

When Using This Product keep out of eyes,ears and mouth.In case of contact with eyes,rinse thoroughly with water.

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

On Children

Keep out of reach of children. If swallowed,get medical help or contact the poison control center immediately.

Directions

Rub cloth between hands for complete cleansing and let hands air dry.

Wipe surface thoroughly and alow to dry.

Children under 6 years of age should be supervised when using.

Discard each wipe after single use.

Inactive Ingredients

Water(Aqua),Propylene Glycol,DidecyldimoniumChloride , Chlorphenesin, Phenoxyethanol,PEG-40 Hydrogenated Castor Oil,Sambucus Nigra Oil,Echinacea Purpurea Extract

* Please review the disclaimer below.