NDC 75817-001 Senchuan Jingshijie Hand Sanitizer

Ethyl Alcohol

NDC Product Code 75817-001

NDC CODE: 75817-001

Proprietary Name: Senchuan Jingshijie 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: Ethyl Alcohol 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

  • 75817 - Senchuan Kazuo Ecological Technology Development Co. Ltd

NDC 75817-001-01

Package Description: 100 mL in 1 BOTTLE

NDC 75817-001-02

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Senchuan Jingshijie Hand Sanitizer with NDC 75817-001 is a a human over the counter drug product labeled by Senchuan Kazuo Ecological Technology Development Co. Ltd. The generic name of Senchuan Jingshijie Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Senchuan Kazuo Ecological Technology Development 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.

Senchuan Jingshijie 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 62 g/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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Senchuan Kazuo Ecological Technology Development Co. Ltd
Labeler Code: 75817
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.

Senchuan Jingshijie Hand Sanitizer Product Label Images

Senchuan Jingshijie 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)

Ethyl Alcohol 62.0%

Purpose

Antiseptic

Uses

  • To decrease bacteria on the skin that could cause disease.For hand use only, recommended for repeated use.

Warnings

  • External uses only, do not swallow or inhale.If swallowed, get medical help or contact a Poison Control Center right away.Avoid contact with eyes, in case of contact rinse eyes thoroughly with water.Combustible. keep away from heat and flame.Allow to dry before getting near fire and sparks.Do not use if sensitive to alcohol. Consult physicians if needed.

Keep Out Or Reach Of Children

  • Keep away from children.

Directions

  • Squeeze small amount of product on palm, rub thoroughly around all fingers and allow to work 30 seconds.No need to rinse.Supervise children under 6 years in the use of this product.

Storage

  • Store in original container closed.Keep in cool, dry and well-ventilated areas.Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients

Water, Trolamine, Glycerin, Carbomer, Tocopherol Acetate, Aloe Vera.

* Please review the disclaimer below.