NDC 10237-670 Essentials Healthy Teeth And Gums

Sodium Fluoride 0.24%

NDC Product Code 10237-670

NDC CODE: 10237-670

Proprietary Name: Essentials Healthy Teeth And Gums What 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: Sodium Fluoride 0.24% What 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

NDC 10237-670-09

Package Description: 1 TUBE in 1 CARTON > 25 g in 1 TUBE

NDC 10237-670-43

Package Description: 1 TUBE in 1 CARTON > 121 g in 1 TUBE

NDC Product Information

Essentials Healthy Teeth And Gums with NDC 10237-670 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Essentials Healthy Teeth And Gums is sodium fluoride 0.24%. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Church & Dwight Co., 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.

Essentials Healthy Teeth And Gums 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.

  • CALCIUM CATION (UNII: 2M83C4R6ZB)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

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.
  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Church & Dwight Co., Inc.
Labeler Code: 10237
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: 12-01-2019 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: 12-31-2021 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.

Essentials Healthy Teeth And Gums Product Label Images

Essentials Healthy Teeth And Gums 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

Sodium fluoride 0.24%

Otc - Purpose

Anticavity toothpaste

Indications & Usage

Use aids in the prevention of dental decay

Warnings

Do not use if irritation occurs and persists.

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.

Directions

  • Do not swallowsupervise children as necessary until capable of using without supervisionrinse away toothpaste residue thoroughly after brushingadults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
  • Children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)
  • Children under 2 years - ask a dentist or physician

Inactive Ingredient

Sodium bicarbonate (baking soda), PEG-8, hydrated silica, glycerin, calcium sulfate, flavor, sodium methyl cocoyl taurate, potassium phosphate, sodium carbonate, xanthan gum, rebaudiana A (stevia leaf extract)

Otc - Questions

Questions or comments? Call
1-800-786-5135 Mon.-Fri. 9am-5pmET or visit
www.myoralcare.com

* Please review the disclaimer below.