NDC 80107-002 M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse

Benzalkonium Chloride

NDC Product Code 80107-002

NDC CODE: 80107-002

Proprietary Name: M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse 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: Benzalkonium Chloride 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

NDC 80107-002-01

Package Description: 60 mL in 1 BOTTLE

NDC 80107-002-02

Package Description: 250 mL in 1 BOTTLE

NDC 80107-002-03

Package Description: 500 mL in 1 BOTTLE

NDC 80107-002-04

Package Description: 750 mL in 1 BOTTLE

NDC 80107-002-05

Package Description: 1000 mL in 1 BOTTLE

NDC 80107-002-06

Package Description: 3785 mL in 1 BOTTLE

NDC Product Information

M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse with NDC 80107-002 is a a human over the counter drug product labeled by Guangzhou Techin Development Co., Ltd. The generic name of M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse is benzalkonium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Guangzhou Techin Development Co., Ltd

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse 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 .13 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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • DISODIUM HEDTA (UNII: KME849MC7A)

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.

Product Labeler Information

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

Labeler Name: Guangzhou Techin Development Co., Ltd
Labeler Code: 80107
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: 12-21-2020 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.

M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse Product Label Images

M Marvel Sani Care Multi Function Disinfectant Liquid No Rinse 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

Benzalkonium Chloride  0.02%

Purpose

Antiseptic

Use

For Daily and Surgical hand disinfection to reduce bacteria on hands

Warnings

For external use only.


Keep away from fires and high temperatures.


Do Not Use: On open skin wounds.

Otc - When Using

When using this product: Avoid eyes.


In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use If irritation or rash occurs. If condition persists, contact a health care practitioner.

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.

Directions

  • Put proper amount (around 3ml) onto palm and rub hands briskly until dry.No washing or rinsing required. Air dries quickly.

Other Information

Keep in closed container in a cool dry place of ambient temperature.


Batch and MFG date printed on bottle.


Validity: 24 months from MFG date.


MADE IN CHINA

Inactive Ingredients

Didecyl Dimethyl Ammonium Chloride, Ethyl Alcohol, Disodium EDTA, Water

* Please review the disclaimer below.