NDC 70602-005 Exoden Cavity

Silicon Dioxide, Aluminum Chlorohydroxy Allantoinate, Sodium Monofluorophosphate

NDC Product Code 70602-005

NDC 70602-005-02

Package Description: 1 TUBE in 1 CARTON > 120 g in 1 TUBE (70602-005-01)

NDC Product Information

Exoden Cavity with NDC 70602-005 is a a human over the counter drug product labeled by Lifeon Corp.. The generic name of Exoden Cavity is silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate. The product's dosage form is paste and is administered via topical form.

Labeler Name: Lifeon Corp.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Exoden Cavity 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.

  • ALCLOXA .16 g/100g
  • SILICON DIOXIDE 15 g/100g
  • SODIUM MONOFLUOROPHOSPHATE .76 g/100g

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
  • XYLITOL (UNII: VCQ006KQ1E)
  • GLUCOSYL STEVIOL (UNII: TKD5UC898Q)
  • LEMON (UNII: 24RS0A988O)
  • LIME (CITRUS) (UNII: 8CZS546954)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
  • POTASSIUM NITRATE (UNII: RU45X2JN0Z)
  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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: Lifeon Corp.
Labeler Code: 70602
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-10-2021 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Exoden Cavity Product Label Images

Exoden Cavity 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

Silicon dioxide 15%Alcloxa 0.16%Sodium Monofluorophosphate 0.76%

Otc - Purpose

Anti plaquePeriodontal disease preventionAnti-cavity

Indications & Usage

Aids in prevention of dental cavities

Dosage & Administration

Supervise children as necessary until capable of using without supervision


Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physicianChildren under 12 years: Instruct in good brushing and rinsing habits (to minimize swallowing)Children under 6 years: Do not use unless directed by a dentist or a physician

Warnings

Ask a dentist before use if you have


• bleeding or redness lasting more than 2 weeks


• pain, swelling, pus, loose teeth, or more spacing between teeth


These may be signs of periodontitis, a serious form of gum disease

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredient

Glycerin, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Hydroxyapatite, Dental-Type Silica, Hydrated Silicon Dioxide, Xylitol, Glucosyl Stevioside, Protease, Lemon Extract, Lime Extract, Sodium Chloride, Tricalcium Phosphate, Potassium nitrate, Sodium Cocoyl Glutamate, Propolis Extract, Green Tea Extract, Mastic Oil, Chamaecyparis Obtusa Oil, Peppermint Oil, Eucalyptus Globulus Leaf Oil, L-Menthol, Titanium Oxide, Purified Water

* Please review the disclaimer below.