NDC 69951-002 Prevention Mouth Rinse

Hydrogen Peroxide

NDC Product Code 69951-002

NDC Code: 69951-002

Proprietary Name: Prevention Mouth Rinse Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrogen Peroxide Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 69951 - Prevention Health Sciences, Inc.
    • 69951-002 - Prevention Mouth Rinse

NDC 69951-002-16

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Prevention Mouth Rinse with NDC 69951-002 is a a human over the counter drug product labeled by Prevention Health Sciences, Inc.. The generic name of Prevention Mouth Rinse is hydrogen peroxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Prevention Health Sciences, Inc.

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 Additional informationCallout TooltipWhat 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.


Prevention Mouth Rinse Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1.5 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • SACCHARIN (UNII: FST467XS7D)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • ZINC CHLORIDE (UNII: 86Q357L16B)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Prevention Health Sciences, Inc.
Labeler Code: 69951
FDA Application Number: part356 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-29-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Prevention Mouth Rinse Product Label Images

Prevention Mouth Rinse 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

Otc - Active Ingredient

Active ingredientHydrogen peroxide 1.5%

Otc - Purpose

PurposeOral debriding agent / Antiseptic

Indications & Usage

  • Uses first aid to help reduce the risk of infection in minor cuts and scrapes caused bydenturesdental proceduresorthodontic appliancesaccidental injuryaids in the removal of phlegm, mucus or other secretions associated with occasional sore mouthfor temporary use to cleanse canker sores, minor wounds and gum irritation

Otc - Do Not Use

Do not use for more than 7 days unless directed by a dentist or doctor

Otc - Stop Use

  • Stop use and ask a doctor ifsore mouth symptoms do not improve within 7 daysirritation, 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

  • Directionsadults and children 2 years of age and older: swish one capful (10 ml) around in mouth over affected area for at least one 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 product.children under 2 years of age: consult a dentist or doctor.

Storage And Handling

  • Other informationkeep away from heat or direct sunlightDo not use if safey seal under cap is broken or missing

Inactive Ingredient

Inactive ingredients water, glycerin, poloxamer 407, sodium lauryl sulfate, disodium EDTA, Mentha piperita (peppermint) oil, sodium citrate, sodium saccharin, citric acid, zinc chloride, menthol

Other

Questions? (800) 473-1205Manufactured by:Prevention Health Sciences, Inc.Raleigh, IL 62977

* Please review the disclaimer below.

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