NDC 37000-995 Crest Premium Plus Sensitivity Active Foam

Sodium Fluoride And Potassium Nitrate

NDC Product Code 37000-995

NDC CODE: 37000-995

Proprietary Name: Crest Premium Plus Sensitivity Active Foam 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 And Potassium Nitrate 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.

Product Characteristics

Color(s):
BLUE (C48333)
Flavor(s):
MINT (C73404)

NDC Code Structure

  • 37000 - The Procter & Gamble Manufacturing Company

NDC 37000-995-70

Package Description: 1 TUBE in 1 CARTON > 198 g in 1 TUBE

NDC Product Information

Crest Premium Plus Sensitivity Active Foam with NDC 37000-995 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Crest Premium Plus Sensitivity Active Foam is sodium fluoride and potassium nitrate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: The Procter & Gamble Manufacturing Company

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.

Crest Premium Plus Sensitivity Active Foam 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.

  • POTASSIUM NITRATE 50 mg/g
  • SODIUM FLUORIDE 1.4 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.

  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ALCOHOL (UNII: 3K9958V90M)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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.

Product Labeler Information

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

Labeler Name: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 01-07-2021 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Crest Premium Plus Sensitivity Active Foam Product Label Images

Crest Premium Plus Sensitivity Active Foam 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

Other

Drug Facts

Dist. by Procter & Gamble, Cincinnati, OH 45202

Otc - Purpose

Active ingredientsPurposePotassium nitrate 5%Toothpaste for sensitive teethSodium fluoride 0.243% (0.14% w/v fluoride ion)Toothpaste for cavity prevention

Uses

  • When used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contactaids in the prevention of cavities

Otc - When Using

When using this product do not use longer than four weeks unless recommended by a dentist.

Otc - Stop Use

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Do not swallow12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.do not use in children under 12 yrs.

Inactive Ingredients

Water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, alcohol (0.7%), sodium saccharin, xanthan gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1

Questions?

1-800-492-7378

* Please review the disclaimer below.