NDC 67751-001 Hydrogen Peroxide

Hydrogen Peroxide

NDC Product Code 67751-001

NDC 67751-001-04

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Hydrogen Peroxide with NDC 67751-001 is a a human over the counter drug product labeled by Navajo Manufacturing Company Inc.. The generic name of Hydrogen Peroxide is hydrogen peroxide. The product's dosage form is solution and is administered via topical form.

Labeler Name: Navajo Manufacturing Company Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Hydrogen Peroxide 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 3 mL/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.

Product Labeler Information

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

Labeler Name: Navajo Manufacturing Company Inc.
Labeler Code: 67751
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: 04-24-2013 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.

Hydrogen Peroxide Product Label Images

Hydrogen Peroxide 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

Hydrogen Peroxide (stabilized 3%)

Purpose

First aid antiseptic/Oral debriding agent

Uses

  • First aid to help prevent the risk of infection in minor cuts, scrapes and burnsaids in the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Warnings

For external use only

Do Not Use

  • In the eyes or apply over large areas of the bodylonger than 1 week

Stop Use And Ask A Doctor If

  • The condition persists or gets worsesore mouth symptoms do not improve in 7 daysirritation, pain, or redness persists or worsensswelling, rash, or fever develops

Directions

  • First aid antiseptic:clean the affected areaapply a small amount of product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry firstOral debriding agent (oral rinse):adults and children 2 years of age and over:mix with an equal amount of waterswish around in the mouth over the affected area for at least 1 minute and then spit outuse up to 4 times daily after meals and at bedtime or as directed by a dentist or doctorchildren under 12 years of age should be supervised in the use of this productchildren under 2 years of age: consult a dentist or doctor

Other Information

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

Purified water

* Please review the disclaimer below.