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| Product NDC Code | 55346-0408 | ||||
|---|---|---|---|---|---|
| Drug Name | Home care fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL, ORAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M021 | ||||
| Labeler Name | Dental Technologies, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous Fluoride 0.4% (0.12% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps aid in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Home Care Fluoride Stannous Fluoride ASCORBIC ACID ANHYDROUS CITRIC ACID GLYCERIN TROLAMINE STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) Grape
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel alpha-dent® HOME CARE FLUORIDE GEL 0.4% STANNOUS FLUORIDE AIDS IN THE PREVENTION OF DENTAL CAVITIES GRAPE REF 004.0802.001 NET WEIGHT - 4.3 oz. (121.9g) DENTAL TECHNOLOGIES 6901 N HAMLIN AVENUE LINCOLNWOOD, ILLINOIS 60712 USA www.dentaltech.com Stannous_grape_image.jpg
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Do not use if foil seal under the cap is torn, cut or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1.800.835.0885 or 847.677.5500
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API