NDC 72655-200 Preop

Hydrogen Peroxide

NDC Product Code 72655-200

NDC 72655-200-01

Package Description: 475 mL in 1 BOTTLE, PUMP

NDC Product Information

Preop with NDC 72655-200 is a a human over the counter drug product labeled by Everbrands, Inc.. The generic name of Preop is hydrogen peroxide. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Everbrands, Inc.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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.

Preop 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.

  • HYDROGEN PEROXIDE 26.5 mg/mL

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.

  • ETIDRONIC ACID (UNII: M2F465ROXU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • 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.

  • 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: Everbrands, Inc.
Labeler Code: 72655
FDA Application Number: part356 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: 03-01-2021 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.

Preop 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

Other

DRUG FACTS

Otc - Active Ingredient

​Active ingredientHydrogen Peroxide 2.65%​​

Otc - Purpose

Purposeantiseptic oral rinse

Indications & Usage

  • Usesfor dental procedural rinsingto help prevent infection in minor oral irritations

Warnings

WarningsDo not use this product for more than 7 days unless directed by a dentist or physician.

Otc - When Using

When using this product, do not swallow

Otc - Stop Use

  • Stop use and ask a doctor ifsore mouth symptoms do not improve within 7 daysirritations, pain or redness persists or worsensswelling, rash or fever develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

Dosage & Administration

Directions:• Adults and children 2 years of age and older: rinse two pumps (4-5 mL)  around in the mouth over the affected area for at least 15 seconds, then spit out• Children under 12 years of age should be supervised in the use of this product• Children under 2 years of age: consult a dentist or physician

Other Safety Information

Other Informationstore at controlled room temperature 68-77°F (20 - 25°C)

Inactive Ingredient

Inactive Ingredients:Etidronic acid, glycerine, menthe arvensis oil, PEG, PVP, sodium benzoate, sodium citrate, sodium lauryl sulfate, sucralose, water

Otc - Questions

Questions?  +1 (855) 595-2999

* Please review the disclaimer below.