NDC 80201-200 Anvi

Benzalkonium Chloride

NDC Product Code 80201-200

NDC 80201-200-01

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC 80201-200-02

Package Description: 108 mL in 1 BOTTLE, PUMP

NDC 80201-200-03

Package Description: 167 mL in 1 BOTTLE, PUMP

NDC 80201-200-04

Package Description: 237 mL in 1 BOTTLE, PUMP

NDC 80201-200-05

Package Description: 473 mL in 1 BOTTLE, PUMP

NDC 80201-200-06

Package Description: 946 mL in 1 BOTTLE, PUMP

NDC 80201-200-07

Package Description: 3785 mL in 1 BOTTLE, PUMP

NDC 80201-200-08

Package Description: 18925 mL in 1 PAIL

NDC 80201-200-09

Package Description: 208173 mL in 1 DRUM

NDC 80201-200-10

Package Description: 1040864 mL in 1 CONTAINER

NDC Product Information

Anvi with NDC 80201-200 is a a human over the counter drug product labeled by Anvi Llc. The generic name of Anvi is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Anvi Llc

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.

Anvi 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • WATER (UNII: 059QF0KO0R)

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: Anvi Llc
Labeler Code: 80201
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: 08-26-2020 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.

Anvi 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 .13%..... Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use(S)

Hand and skin sanitizer to decrease microbes on the skin. For use when hand washing is not available.

Warnings

For external use only. Keep out of ears, eyes or mouth. In case of contact with eyes, flush with water.
Stop use and ask doctor: If redness or irritation develops and persists for more than 72 hours.
Keep out of reach of children: If swallowed, get medical help or contact a Cpoison Control Center right away.

Do Not Use

Stop use and ask a doctor: If redenss or irritation develops and persists for more than 72 hours.

Directions

Directions: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.
Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.

Stop Use And Ask A Doctor

Stop use and ask a doctor: If redness or irritation develops and persists for more than 72 hours.

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: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

Directions For Use

Directions: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.
Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.

Other Information

Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.

Inactive Ingredients

Water. Colloidal Silicon Dioxide

Questions-Information

Www.getanvi.com

* Please review the disclaimer below.