NDC 78315-201 Tanyuansu Disinfectant

Disinfectant

NDC Product Code 78315-201

NDC 78315-201-17

Package Description: 140 BOTTLE, PUMP in 1 CARTON > 100 mL in 1 BOTTLE, PUMP (78315-201-01)

NDC Product Information

Tanyuansu Disinfectant with NDC 78315-201 is a a human over the counter drug product labeled by Qinhe (hubei) Biotechnology Co., Ltd.. The generic name of Tanyuansu Disinfectant is disinfectant. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Qinhe (hubei) Biotechnology 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.

Tanyuansu Disinfectant 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.

  • BENZALKONIUM CHLORIDE 100 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)

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: Qinhe (hubei) Biotechnology Co., Ltd.
Labeler Code: 78315
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: 06-01-2020 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.

Tanyuansu Disinfectant Product Label Images

Tanyuansu Disinfectant 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)

Benzalkonium chloride 1mg/mL. Purpose: Antimicrobial

Purpose

Antimicrobial.

Use

This product is indicated use to kill enteropathogenic bacteri, pyogenic coccus, pathogenic fungia and common infected bacteria in hospitals.1. Applied to the disinfection of the skin surfaces.2. Applied to the disinfection of environment, surfaces like toys, keyboard, mobile-phones, car ornaments, masks, gloves, shoes, socks, clothing, leather, desktop, cotton and textiles disinfection, etc.

Warnings

For external use only, oral administration is prohibited.

Do Not Use

  • On children less than 2 months of ageon open skin wounds

Otc - When Using

When using: avoid direct contact with eyes and damaged skin; if it gets in your eyes accidentally, please rinse with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

1. Take appropriate amount of the disinfectant to or spray on the skin surface until moist, duration for 3 minutes.2. Spray to the surface of targeted object till its wet or take small objects into this disinfectant directly, duration for 5 minutes.

Other Information

Stored in dry place at common temperature.

Inactive Ingredients

Trihydroxysilylpropyldimethyloctadecyl ammonium chloride, Purified water.

* Please review the disclaimer below.