Crest Pro-health Gum Detoxify Charcoal Mint
Stannous Fluoride
The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 69423-951Crest Pro-health Gum Detoxify Charcoal Mint also known as Stannous Fluoride is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Crest Pro-health Gum Detoxify Charcoal Mint is 69423-951. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Crest Pro-health Gum Detoxify Charcoal Mint drug includes Stannous Fluoride - 1.4 mg/g . The currest status of Crest Pro-health Gum Detoxify Charcoal Mint drug is Active.
Drug Information:
| Drug NDC: | 69423-951 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Crest Pro-health Gum Detoxify Charcoal Mint |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Crest Pro-health |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Gum Detoxify Charcoal Mint |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Stannous Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Procter & Gamble Manufacturing Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste, Dentifrice |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | STANNOUS FLUORIDE - 1.4 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part355 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | The Procter & Gamble Manufacturing Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 416784
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3FTR44B32Q
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69423-951-41 | 1 TUBE in 1 CARTON (69423-951-41) / 116 g in 1 TUBE | 01 Jun, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purposes anticavity, antigingivitis toothpaste
Product Elements:
Crest pro-health gum detoxify charcoal mint stannous fluoride activated charcoal sucralose stannous chloride water hydrated silica carrageenan sodium gluconate xanthan gum zinc citrate sodium lauryl sulfate sorbitol sodium hydroxide saccharin sodium sodium citrate stannous fluoride fluoride ion
Indications and Usage:
Uses aids in the prevention of cavities helps prevent gingivitis helps interfere with the harmful effects of plaque associated with gingivitis helps control plaque bacteria that contribute to the development of gingivitis
Warnings:
Warning keep out of reach of children under 12 yrs. of age . if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
Warnings and Cautions:
Other information products containing stannous fluoride may produce surface staining of the teeth adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist this crest is specially formulated to help prevent staining see your dentist regularly
Dosage and Administration:
Directions adults and children 12 yrs. of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs. of age: ask a dentist
Package Label Principal Display Panel:
Principal display panel - 116 g tube in carton crest ® pro-health fluoride toothpaste for anticavity and antigingivitis gum detoxify neutralizes plaque bacteria, evenaround the gumline, for 24 hours* charcoal mint net wt 4.1 oz (116 g) 69423951
Further Questions:
Questions? 1-800-492-7378