NDC 80928-201 O2safe

Chlorite Ion

NDC Product Code 80928-201

NDC 80928-201-01

Package Description: 100 mL in 1 BOTTLE

NDC 80928-201-02

Package Description: 500 mL in 1 BOTTLE

NDC 80928-201-03

Package Description: 1000 mL in 1 BOTTLE

NDC 80928-201-04

Package Description: 20000 mL in 1 BOTTLE

NDC Product Information

O2safe with NDC 80928-201 is a a human over the counter drug product labeled by O2ns. The generic name of O2safe is chlorite ion. The product's dosage form is liquid and is administered via topical form.

Labeler Name: O2ns

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.

O2safe 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.

  • CHLORITE ION .1 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)

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: O2ns
Labeler Code: 80928
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-31-2020 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.

O2safe 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

Chlorine dioxide ion(1-) (CLO2 0.1%)

Purpose

Antiseptic

Uses

Eliminate harmful bacteria and viruses that can cause disease. Recommended for repeated use.

Warnings

Keep away from fire or flame. Do not use it directly on the human body.

Ask A Doctor

In case of contact with eyes, flush thoroughly with water.If swallowed, get medical help or contact a Posion Control Center immediately.

Keep Out Of Reach Of Children.

Swallowed, get medical help or contact a Poison Control Center right away.

When Using This Product

If in eyes, rinse promptly and thoroughly with water.

Directions

Maintain a proper distance of 20 to 30cm when spraying the product. Use leather goods after experiment.

Inactive Ingredient

Purified water

* Please review the disclaimer below.