NDC 73051-0754 Orthocare

Sodium Fluoride

NDC Product Code 73051-0754

NDC 73051-0754-1

Package Description: 125 g in 1 TUBE

NDC Product Information

Orthocare with NDC 73051-0754 is a a human over the counter drug product labeled by Orthosciences, Inc.. The generic name of Orthocare is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental; oral form.

Labeler Name: Orthosciences, Inc.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.


Orthocare 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.

  • SODIUM FLUORIDE 2.4 mg/g

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.

  • ALANINE (UNII: OF5P57N2ZX)
  • SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SACCHARIN (UNII: FST467XS7D)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • MINT (UNII: FV98Z8GITP)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • WATER (UNII: 059QF0KO0R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ARGININE (UNII: 94ZLA3W45F)
  • LYSINE (UNII: K3Z4F929H6)
  • SODIUM LAURYL PHOSPHATE (UNII: 9ECT856LYU)

Administration Route(s)

What 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.
  • 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: Orthosciences, Inc.
Labeler Code: 73051
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-17-2019 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: 12-31-2020 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.

Orthocare Product Label Images

Orthocare 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

Inactive Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

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.

Other Information:

For your protection, this tube has a foil seal under the cap.

Directions

  • Adults and children 2 years of age and older: Use a pea sized amount and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children's brushing until good habits are established.Children under 2 years: Consult a dentist or doctor.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Lysine, Arginine, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose Gum, Alanine, Sodium Benzoate, Disodium Phospate, Sodium Saccharin, FD&C Blue #1

Questions?

1-833-261-0246

Principal Display

OrthoSciences™ORTHOCARESpecially formulated for those with bracesNET WT. 4.4 OZ. (125 grams) Anticavity Fluoride Toothpaste

* Please review the disclaimer below.

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