NDC 75704-005 Rinse-free Hand Sanitizer

Rinse-free Hand Sanitizer

NDC Product Code 75704-005

NDC 75704-005-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Rinse-free Hand Sanitizer with NDC 75704-005 is a a human over the counter drug product labeled by Jiangsu Bijie Biomedical Co., Ltd.. The generic name of Rinse-free Hand Sanitizer is rinse-free hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Jiangsu Bijie Biomedical Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Rinse-free 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.

  • ALCOHOL 75 mL/100mL

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.

  • ROSE OIL (UNII: WUB68Y35M7)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER 934 (UNII: Z135WT9208)
  • 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: Jiangsu Bijie Biomedical Co., Ltd.
Labeler Code: 75704
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: 04-30-2020 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.

Rinse-free Hand Sanitizer Product Label Images

Rinse-free 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

Main Contents

Ethanol 75%

Inactive Ingredients

Carbomer, Glycerol, Rose Essence, Distilled Water

Antibacteria

Pathogenic Entero Bacteria, Pyococcus, Pathogenic Yeasts and common bacteria. etc

Application

Skin and hands disinfection.

Usage

Press the pump gently to get a suitable amount of sanitizer on palm, rub hands or smear it to the skin surface equally without rinse

Notes

1. For external use only, not be oral. Keep out of reach of children.

2. Avoid eyes contact, if contact rinse thoroughly with clear water immediatel

3. This product contains ethanol which would imitate the wound and mucous, and please use with caution for persons allergic to alcohol

4.Flammable, keep away from fire

Storage

Keep it sealed in a cool, ventilated and dry place at RTExpiration: 24 months

* Please review the disclaimer below.