Alpha-pro
Sodium Fluoride And Hydrofluoric Acid
Dental Technologies, Inc.
Human Prescription Drug
NDC 55346-0942Alpha-pro also known as Sodium Fluoride And Hydrofluoric Acid is a human prescription drug labeled by 'Dental Technologies, Inc.'. National Drug Code (NDC) number for Alpha-pro is 55346-0942. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Alpha-pro drug includes Hydrofluoric Acid - 4.4 mg/g Sodium Fluoride - 7.9 mg/g . The currest status of Alpha-pro drug is Active.
Drug Information:
| Drug NDC: | 55346-0942 |
| 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: | Alpha-pro |
| 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: | Sodium Fluoride And Hydrofluoric Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dental Technologies, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | HYDROFLUORIC ACID - 4.4 mg/g
SODIUM FLUORIDE - 7.9 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: | 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 Apr, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Jan, 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, 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: | Dental Technologies, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297381
|
| 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: | RGL5YE86CZ
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 |
|---|
| 55346-0942-1 | 497 g in 1 BOTTLE (55346-0942-1) | 01 Apr, 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:
Alpha-pro sodium fluoride and hydrofluoric acid sodium fluoride fluoride ion hydrofluoric acid fluoride ion strawberry
Indications and Usage:
Indications and usage: topical application of apf gel is indicated in the prevention of dental caries. this treatment is normally used two times per year and should not exceed four times a year.
Warnings:
Warning: keep out of reach of children. do not swallow. if swallowed during treatment, administer milk, limewater, or antacid. if larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. contains fd&c red no. 40.
Dosage and Administration:
Dosage and administration: after thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). throughly air-dry teeth and insert tray(s) in mouth. gel may also be swab applied. instruct patient to bite down slightly but firmly for one to four minutes. a slight chewing motion enhances coverage interproximally. remove tray(s) and have patient expectorate excess gel. instruct patient not to eat, drink or rinse for at least 30 minutes.
Contraindications:
Contraindications: hypersensitivity to fluoride.
Adverse Reactions:
Adverse reactions: developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. the following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.
Description:
Active ingredients: 1.23% w/w fluoride ion (0.79% from sodium fluoride and 0.44% from hydrogen fluoirde) in 0.1 molar phosphoric acid. dental technologies lincolnwood, illinois 60712 usa www.dentaltech.com questions or comments? call: 1-800-835-0885 (us) or 1-847-677-5500 pm-5097 rev002
How Supplied:
How supplied: a gel, one bottle contains up to 68 individual applications. store at controlled room temperature 20°- 25°c (68°-77°f). do not allow to freeze.
Package Label Principal Display Panel:
Principal display panel dental technologies www.dentaltech.com alpha-pro® apf topical gel 60 second treatment acidulated phosphate fluoride 1.23% fluoride ion rx only strawberry ref no. 009-4201-002 net weight: 17.5 oz. (497g) apf_strawberry