NDC 77332-001 Disposable Hand Sanitiser

Alcohol

NDC Product Code 77332-001

NDC 77332-001-01

Package Description: 500 g in 1 BOTTLE

NDC Product Information

Disposable Hand Sanitiser with NDC 77332-001 is a a human over the counter drug product labeled by Guangzhou Taimei Trading Co., Ltd.. The generic name of Disposable Hand Sanitiser is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Guangzhou Taimei Trading 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.

Disposable Hand Sanitiser 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/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.

  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

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: Guangzhou Taimei Trading Co., Ltd.
Labeler Code: 77332
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: 05-07-2020 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.

Disposable Hand Sanitiser Product Label Images

Disposable Hand Sanitiser 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)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

This product mainly contains ethanolm jojoba seed oil and aloe vera essence, which can effectively clean and maintain the skin on the hands, and it is quick-drying and non-sticky.

Warnings

Highly flammable. Keep away from fire or flame. For external use only.

Otc - When Using

Avoid eyes. In case of eye contact, flush with water

Otc - Stop Use

Discontinue use if skin irritation occurs. If condition persists see a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, contact Poison Control Center or a doctor.

Directions

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

Other Information

Store between 15-30C (59-86F)

Inactive Ingredients

Aloe barbadensis leaf juice, Glycerin, Tocopheryl acetate, Parfum, Acrylate/C10-30 alkyl acrylate crosspolymer, Amino-methyl-propanediol, water

* Please review the disclaimer below.