NDC 52728-020 Pro-tex Hand Sanitizer

Hand Sanitizer

NDC Product Code 52728-020

NDC 52728-020-01

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Pro-tex Hand Sanitizer with NDC 52728-020 is a a human over the counter drug product labeled by Zhejiang Enchant Cosmetic Co., Ltd.. The generic name of Pro-tex Hand Sanitizer is hand sanitizer. The product's dosage form is gel and is administered via extracorporeal form.

Labeler Name: Zhejiang Enchant Cosmetic 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.

Pro-tex 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 177.75 mL/237mL

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.

  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Extracorporeal - Administration outside of the body.
  • Extracorporeal - Administration outside of the body.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Zhejiang Enchant Cosmetic Co., Ltd.
Labeler Code: 52728
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: 07-10-2020 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.

Pro-tex Hand Sanitizer Product Label Images

Pro-tex 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)

75% Alcohol(V/V).

Purpose

Antibacterial and dialy hand cleaning.Have antibacterial effect to staphylococcus aureus, escherichia coli, candida albicans.

Use

Squeeze out a small amount of formula properly and knead it with both hands.

Lasting for 1-3 minutes.

Warnings

Do not take the external product orally;

Do not touch the wound;

Do not contact the child directly;

If you contact the eyes carelessly, wash them with water in time;

Do not use this product instead of drugs;

Do not use it if you are allergic to alcohol.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Keep away from sunlight and store in a cool and dry place.

Inactive Ingredients

Water(Aqua), Carbomer, Aminomethyl propanol, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate.

* Please review the disclaimer below.