NDC 59883-017 Perio Daily Defense

Hydrogen Peroxide Gel

NDC Product Code 59883-017

NDC Code: 59883-017

Proprietary Name: Perio Daily Defense 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 Gel 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
  • 59883 - Den-mat Holdings, Llc.
    • 59883-017 - Perio Daily Defense

NDC 59883-017-85

Package Description: 1 TUBE in 1 BOX > 85 g in 1 TUBE

NDC Product Information

Perio Daily Defense with NDC 59883-017 is a a human over the counter drug product labeled by Den-mat Holdings, Llc.. The generic name of Perio Daily Defense is hydrogen peroxide gel. The product's dosage form is gel and is administered via dental form.

Labeler Name: Den-mat Holdings, Llc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.


Perio Daily Defense 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 17 mg/g

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.

  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SACCHARIN (UNII: FST467XS7D)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBITOL (UNII: 506T60A25R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • MENTHOL (UNII: L7T10EIP3A)
  • WATER (UNII: 059QF0KO0R)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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.

  • Dental - Administration to a tooth or teeth.

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: Den-mat Holdings, Llc.
Labeler Code: 59883
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: 01-16-2019 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.

Perio Daily Defense Product Label Images

Perio Daily Defense 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 Ingredients

Hydrogen Peroxide1.7% w/w

Purpose

Wound Cleanser

Indications & Uses

For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis.

Warnings

  • Do not use Perio Daily Defense Gel for more than 7 days unless directed by your dentist or physician. Stop use and ask your dentist or physician if:Symptoms of wounds or inflammation do not improve within 7 days.Irritation, pain or redness persists or worsensSwelling, rash or fever develops

Keep Out Of Reach Of Children.

Children under 12 years of age should be supervised when using this product.

Directions

For children under 2 years of age, consult a dentist or physician.For adults and children 2 years of age or older:1. Apply several drops of gel directly onto the affected area in the mouth.2. Leave the material on the affected area for at least 60 seconds, then spit.3. Use up to 4 times daily after meals and or at bedtime, or as directed by a dentist or physician.

Other Information

Store at controlled room temperature, 20-25º C (68-77º F) and away from direct sunlight.For your protection, do not use if tamper seal on box is broken or missing.

Inactive Ingredients

Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water.

* Please review the disclaimer below.

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