Act Restoring Anticavity Fluoride Mint Burst
Sodium Fluoride
Chattem, Inc.
Human Otc Drug
NDC 41167-0979Act Restoring Anticavity Fluoride Mint Burst also known as Sodium Fluoride is a human otc drug labeled by 'Chattem, Inc.'. National Drug Code (NDC) number for Act Restoring Anticavity Fluoride Mint Burst is 41167-0979. This drug is available in dosage form of Mouthwash. The names of the active, medicinal ingredients in Act Restoring Anticavity Fluoride Mint Burst drug includes Sodium Fluoride - .5 mg/mL . The currest status of Act Restoring Anticavity Fluoride Mint Burst drug is Active.
Drug Information:
| Drug NDC: | 41167-0979 |
| 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: | Act Restoring Anticavity Fluoride Mint Burst |
| 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: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Chattem, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Mouthwash |
| 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: | SODIUM FLUORIDE - .5 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 16 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 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, 2023 |
| 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: | Chattem, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 240698
656809
|
| 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: | 8ZYQ1474W7
|
| 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 |
|---|
| 41167-0979-0 | 532 mL in 1 BOTTLE, PLASTIC (41167-0979-0) | 16 Dec, 2015 | N/A | No |
| 41167-0979-1 | 30 mL in 1 BOTTLE, PLASTIC (41167-0979-1) | 16 Dec, 2015 | N/A | No |
| 41167-0979-3 | 88 mL in 1 BOTTLE, PLASTIC (41167-0979-3) | 16 Dec, 2015 | 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
Product Elements:
Act restoring anticavity fluoride mint burst sodium fluoride sodium fluoride fluoride ion water sorbitol poloxamer 407 propylene glycol sodium phosphate polysorbate 20 saccharin sodium sucralose sodium phosphate, dibasic, anhydrous cetylpyridinium chloride edetate calcium disodium anhydrous sodium benzoate potassium sorbate fd&c yellow no. 5 fd&c green no. 3
Indications and Usage:
Use aids in the prevention of dental cavities
Warnings:
W arnings keep out of reach of children. if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions a dults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters into cap (10 ml mark on inside of cap); do not fill above 10 ml mark vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision c hildren under 6 years of age: consult a dentist or doctor
Package Label Principal Display Panel:
Principal display panel zero alcohol act 1x daily restoring anticavity fluoride mouthwash mint burst 18 fl oz (532 ml) zero alcohol act 1x daily restoring anticavity fluoride mouthwash mint burst 18 fl oz (532 ml)