NDC 81794-800 Oroxid Forte Oral Hygiene

Hydrogen Peroxide

NDC Product Code 81794-800

NDC 81794-800-20

Package Description: 250 mL in 1 BOTTLE, SPRAY

NDC 81794-800-30

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC Product Information

Oroxid Forte Oral Hygiene with NDC 81794-800 is a a human over the counter drug product labeled by Innova Medical Group. The generic name of Oroxid Forte Oral Hygiene is hydrogen peroxide. The product's dosage form is spray and is administered via oral form.

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.

Oroxid Forte Oral Hygiene 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.


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.

  • COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • GINGER (UNII: C5529G5JPQ)
  • ECHINACEA PURPUREA (UNII: QI7G114Y98)
  • STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX)
  • SPEARMINT (UNII: J7I2T6IV1N)
  • PEG-40 CASTOR OIL (UNII: 4ERD2076EF)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Innova Medical Group
Labeler Code: 81794
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: 06-21-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Oroxid Forte Oral Hygiene 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

Keep Out Of Reach Of Children

Keep away from children

Storage And Handling

Store at Temperature of 5ºc to 25ºcProtect from Direct sunlight

Warning

Avoid direct contact with eyes

Innovative Help With

Gingivits, Periodontitis
Inflammation of oral cavityBleeding and irritated gumsIntensive oral hygiene(Fixed dental braces, prosthesis, implants)Reduction of deposit on the tonguePrevention of dental plaqueReduction of tooth stainsRestoration of fresh breath

How To Use

Use OROXID Forte two to three times a day prederably during or after brushing your teech. Spray the solution into the oral cavity with 3 to 4 pressures of the spray, gargle for about 30 seconds and spit it out. Use OROXID forte reqularly, until the situation of elimincation of inflammation immproves.

Dosage Administrationt

3 to 4 pressure of the spray, two to three times a day

Active Ingredient

Hydrogen peroxide

Inactive Ingredient

Deionized water

* Please review the disclaimer below.