Frenna Ac
Aluminum Chloride
Dharma Research, Inc.
Human Prescription Drug
NDC 53045-300Frenna Ac also known as Aluminum Chloride is a human prescription drug labeled by 'Dharma Research, Inc.'. National Drug Code (NDC) number for Frenna Ac is 53045-300. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Frenna Ac drug includes Aluminum Chloride - 8.75 g/35g . The currest status of Frenna Ac drug is Active.
Drug Information:
| Drug NDC: | 53045-300 |
| 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: | Frenna Ac |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Aluminum Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dharma Research, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | ALUMINUM CHLORIDE - 8.75 g/35g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
ORAL
TOPICAL
|
| 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 Jan, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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. |
| 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: | Dharma Research, inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 244613
|
| 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: | 3CYT62D3GA
|
| 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 |
|---|
| 53045-300-30 | 35 g in 1 BOTTLE, PLASTIC (53045-300-30) | 01 Jan, 2013 | 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. |
Product Elements:
Frenna ac aluminum chloride aluminum chloride aluminum cation water potassium chloride propylene glycol benzyl alcohol
Indications and Usage:
Frenna ac is a topical astringent solution of aluminum chloride. gingival retraction can be achieved using a plain gingival retraction cord moistened with frenna ac. stops gingival bleeding fast. if you should anadvertently damage the gingival margin during tooth preparation or while placing a strip, a band, or a cervical matrix, moisten the area with frenna ac which will control and stop bleeding quickly. frenna ac contains no epinephrine. the use of casoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided. a plain gingival retraction cord can be dipped in frenna ac solution and then placed into the gingival sulcus for its hemostatic action.
Warnings and Cautions:
Discontinue use if irritation appears. for topical application only. avoid eye contact. do not use in patients with a known history of hyper sensetivity to aluminum chloride. for professional use only. federal law restricts this product to sale or use on the order of a dentist.
Package Label Principal Display Panel:
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