Total Advanced Health Fresh Mint
Cetylpyridinium Chloride
Colgate-palmolive Company
Human Otc Drug
NDC 35000-390Total Advanced Health Fresh Mint also known as Cetylpyridinium Chloride is a human otc drug labeled by 'Colgate-palmolive Company'. National Drug Code (NDC) number for Total Advanced Health Fresh Mint is 35000-390. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Total Advanced Health Fresh Mint drug includes Cetylpyridinium Chloride - .75 mg/mL . The currest status of Total Advanced Health Fresh Mint drug is Active.
Drug Information:
| Drug NDC: | 35000-390 |
| 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: | Total Advanced Health Fresh Mint |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Cetylpyridinium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Colgate-palmolive Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| 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: | CETYLPYRIDINIUM CHLORIDE - .75 mg/mL
|
| 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 NOT 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: | 09 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| 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: | part356 |
| 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: | 16 Jan, 2025 |
| 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: | Colgate-Palmolive Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1599135
|
| 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. |
| UPC: | 0035000556813
|
| UPC stands for Universal Product Code. |
| UNII: | D9OM4SK49P
|
| 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 |
|---|
| 35000-390-12 | 400 mL in 1 BOTTLE (35000-390-12) | 09 Jan, 2017 | 31 Dec, 2023 | No |
| 35000-390-27 | 800 mL in 1 BOTTLE (35000-390-27) | 12 Jan, 2017 | 31 Dec, 2023 | No |
| 35000-390-68 | 200 mL in 1 BOTTLE (35000-390-68) | 09 Jan, 2017 | 31 Dec, 2023 | 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:
Purpose antigingivitis/antiplaque
Product Elements:
Total advanced health fresh mint cetylpyridinium chloride cetylpyridinium chloride cetylpyridinium water mineral oil glycerin sorbitol benzyl alcohol potassium sorbate sodium benzoate phosphoric acid saccharin sodium sucralose dimethicone sunflower oil beta carotene fd&c blue no. 1
Indications and Usage:
Uses helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
Warnings:
Warnings stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks. you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. these may be signs or symptoms of periodontitis, a serious form of gum disease keep out of reach of children under 6 years of age. if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions shake well to mix the two liquids before each use. adults and children 12 years of age and older rinse for 30 seconds with 20 ml (4 teaspoonfuls) twice a day. do not swallow. children 6 years to under 12 years of age supervise use children under 6 years of age do not use
Package Label Principal Display Panel:
Principal display panel - 200 ml bottle label shake to activate see the results in the sink colgate ® antigingivitis antiplaque mouthwash total ® advanced health helps improve the health of your mouth ? reduces plaque ? freshens breath ? helps prevent gingivitis fresh mint alcohol free 6.7 fl oz (200 ml) p9917057 principal display panel - 200 ml bottle label
Further Questions:
Questions? 1-800-468-6502