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| Product NDC Code | 43498-200 | ||||
|---|---|---|---|---|---|
| Drug Name | Burkhart |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | CONCENTRATE | ||||
| RxCUI drug identifier | 583459 | ||||
| Labeler Name | Burkhart Dental Supply Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.
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.Indications and Usage: Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.
Spl product data elements
Usually a list of ingredients in a drug product.Burkhart Stannous Fluoride GLYCERIN METHYLPARABEN PROPYLPARABEN SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION heavy liquid
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.LB.Burkhart .63 Stann Fl Rinse_mint.jpg BX.Burkhart .63 Stann Fl Rinse.jpg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Active Ingredient: Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).
Purpose: Anticavity, antigingivitis, antihypersensitivity mouthrinse
Instructions for use
Information about safe handling and use of the drug product.Directions: Adults and children 6 years of age and older: Do not use before mixing with water. Use immediately after preparing the rinse. Remove cap and replace with pump. Rotate spout container clockwise to extend. Depress pump until rinse comes to the tip of the pump. Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well. Vigorously swish 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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.
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: Keep out of reach of children. Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use until diluted. This product may produce surface staining of the teeth. Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
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