NDC 52983-001 Tianyang Handsanitizer

Handsanitizer

NDC Product Code 52983-001

NDC 52983-001-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Tianyang Handsanitizer with NDC 52983-001 is a a human over the counter drug product labeled by Anhui Tianyang Pharmaceutical Co., Ltd.. The generic name of Tianyang Handsanitizer is handsanitizer. The product's dosage form is liquid and is administered via extracorporeal form.

Labeler Name: Anhui Tianyang Pharmaceutical 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.

Tianyang Handsanitizer 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 375 mL/500mL

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Anhui Tianyang Pharmaceutical Co., Ltd.
Labeler Code: 52983
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: 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.

Tianyang Handsanitizer Product Label Images

Tianyang Handsanitizer 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

Dosage & Administration

Keep away from light, airtight and in a cool and dry place.

Inactive Ingredient

1,2 propylene glycol

Indications & Usage

1. surgical hand disinfection: take 5ml of this product, rub hands and for earms evenly for 3 minutes, and then wear sterile gloves;

2. disinfection of hands: take 5m| of the original solution of the product and rub it in the palm for 1 minute until it is dry;

3. Hand disinfection in daily work: take about 3ml of the original solution of this product into the palm,rub it with both hands for 1

minute until it is dry.

Otc - Active Ingredient

Alcohol

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

Disinfection

Sterilization

No Rinseing

Warnings

1. This product is an external dis infectant and should not be taken orally;

2. Use with caution if you are allergic to this product;

3. This product is flammable and should be kept away from the fire source;

4. Keep away from light, airtight and in a cool and dry pl ace;

5. Please keep this product out of the reach of chi Idren;

* Please review the disclaimer below.