NDC 78128-201 Juc Rinsefree Anti Microbial Hand Sanitizer

Hand Sanitizer

NDC Product Code 78128-201

NDC CODE: 78128-201

Proprietary Name: Juc Rinsefree Anti Microbial Hand Sanitizer 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: Hand Sanitizer 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

  • 78128 - Nms Technologies Co., Ltd.
    • 78128-201 - Juc Rinsefree Anti Microbial Hand Sanitizer

NDC 78128-201-06

Package Description: 250 mL in 1 BOTTLE, PUMP

NDC Product Information

Juc Rinsefree Anti Microbial Hand Sanitizer with NDC 78128-201 is a a human over the counter drug product labeled by Nms Technologies Co., Ltd.. The generic name of Juc Rinsefree Anti Microbial Hand Sanitizer is hand sanitizer. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Nms Technologies 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.

Juc Rinsefree Anti Microbial Hand Sanitizer 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 750 mg/250mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)

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: Nms Technologies Co., Ltd.
Labeler Code: 78128
FDA Application Number: part333E 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: 06-01-2020 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.

Juc Rinsefree Anti Microbial Hand Sanitizer Product Label Images

Juc Rinsefree Anti Microbial Hand Sanitizer 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)

Benzalkonium chloride 3mg/mL. Purpose: Antimicrobial

Purpose

Antimicrobial.

Use

This product is indicated use to disinfection on surfaces of hands and skin to kill Escherichia coli, Staphylococcus aureus, Candida albicans.

Warnings

This product should not be taken orally, and to avoid contact strong acids and bases.

Do Not Use

  • On children less than 2 months of ageon open skin wounds

Otc - When Using

When using: avoid direct contact with eyes and damaged skin; if it gets in your eyes accidentally, please rinse with water.

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

This product should be placed out of reach of children.

Directions

Press several times, take an appropriate amount of this product to disinfect and wipe your whole hands.

Other Information

Storage in a cool, dry and ventilated place, sealed.

Inactive Ingredients

Glycerol, Propylene glycol, Hydroxyethyl Cellulose, Water.

* Please review the disclaimer below.