NDC 37000-390 Crest Pro-health Gum And Sensitivity Refreshing Mint

Stannous Fluoride

NDC Product Code 37000-390

NDC Code: 37000-390

Proprietary Name: Crest Pro-health Gum And Sensitivity Refreshing Mint 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: Stannous Fluoride 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
  • 37000 - The Procter & Gamble Manufacturing Company
    • 37000-390 - Crest Pro-health

NDC 37000-390-41

Package Description: 1 TUBE in 1 CARTON > 116 g in 1 TUBE

NDC 37000-390-85

Package Description: 1 TUBE in 1 CARTON > 24 g in 1 TUBE

NDC Product Information

Crest Pro-health Gum And Sensitivity Refreshing Mint with NDC 37000-390 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Crest Pro-health Gum And Sensitivity Refreshing Mint is stannous fluoride. 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 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.


Crest Pro-health Gum And Sensitivity Refreshing Mint 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.

  • STANNOUS FLUORIDE 1.4 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.

  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SORBITOL (UNII: 506T60A25R)
  • ZINC CITRATE (UNII: K72I3DEX9B)
  • STANNOUS CHLORIDE (UNII: 1BQV3749L5)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-09-2019 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.

Crest Pro-health Gum And Sensitivity Refreshing Mint Product Label Images

Crest Pro-health Gum And Sensitivity Refreshing Mint 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

DISTR. BY PROCTER & GAMBLE,

















CINCINNATI, OH 45202

Active Ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

Uses

  • Aids in the prevention of cavitieshelps prevent gingivitishelps interfere with the harmful effects of plaque associated with gingivitishelps control plaque bacteria that contribute to the development of gingivitisbuilds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Otc - When Using

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

Otc - Stop Use

Stop use and ask a dentist if the sensitivity problem persists or worsens. 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

  • Adults and children 12 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 swallowchildren under 12 yrs.: ask a dentist

Other Information

  • Products containing stannous fluoride may produce surface staining of the teethadequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentistthis Crest is specially formulated to help prevent stainingsee your dentist regularly

Inactive Ingredients

Water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, stannous chloride, xanthan gum, cocamidopropyl betaine, zinc citrate, sodium saccharin, sucralose, sodium hydroxide, titanium dioxide

Questions?

1-800-594-4158

* Please review the disclaimer below.

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