Cool Sense Stick Gargle
Cetylpyridinium Chloride
Dr.s Medi Co.,ltd.
Human Otc Drug
NDC 76670-0015Cool Sense Stick Gargle also known as Cetylpyridinium Chloride is a human otc drug labeled by 'Dr.s Medi Co.,ltd.'. National Drug Code (NDC) number for Cool Sense Stick Gargle is 76670-0015. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cool Sense Stick Gargle drug includes Cetylpyridinium Chloride - .05 g/100mL . The currest status of Cool Sense Stick Gargle drug is Active.
Drug Information:
| Drug NDC: | 76670-0015 |
| 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: | Cool Sense Stick Gargle |
| 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: | Dr.s Medi Co.,ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - .05 g/100mL
|
| 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: | UNAPPROVED DRUG OTHER |
| 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 Feb, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 2026 |
| 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. |
| 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: | Dr.s Medi Co.,Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 76670-0015-2 | 30 CONTAINER in 1 CARTON (76670-0015-2) / 10 mL in 1 CONTAINER (76670-0015-1) | 01 Feb, 2023 | 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:
Purpose anticavity mouthwash
Product Elements:
Cool sense stick gargle cetylpyridinium chloride cetylpyridinium chloride cetylpyridinium sodium benzoate glycerin
Indications and Usage:
Uses â helps protect against cavities
Warnings:
Warnings â when using this product, if irritation occurs discontinue use, stop use and ask a dentist if â for children under 6 years of age, use small amounts under the supervision of a guardian to avoid sucking or swallowing. â consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. â keep out of the reach of children under 6 years of age.
Dosage and Administration:
Directions â rinse mouth with this coolsense stick gargle 10ml for 60 seconds then expel
Package Label Principal Display Panel:
Package label.principal display panel image of carton
Further Questions:
Questions â https://docsmedi.kr â tel: 82-031-922-2240, fax: 82-43-883-2844