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| Product NDC Code | 59883-018 | ||||
|---|---|---|---|---|---|
| Drug Name | Periorestore |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1095271 | ||||
| Application Number | M022 | ||||
| Labeler Name | DEN-MAT HOLDINGS, LLC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Hydrogen Peroxide 1.7% w/w
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 For children under 2 years of age, consult dentist or physician. For adults and children 2 years of age and older: 1. Apply several drops of gel directly onto the affected area in the mouth. 2. Leave the material on the affected area for at least 60 seconds, then spit. 3. Use up to 4 times daily after meals and or a bedtime, or as directed by a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water.
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 & Uses For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Restore may be used for lessening the presence of plaque, a known factor in development of gingivitis.
Purpose
Information about the drug product’s indications for use.Purpose Wound Cleanser
Spl product data elements
Usually a list of ingredients in a drug product.PerioRestore Hydrogen Peroxide SORBITOL MENTHOL METHYL SALICYLATE PHOSPHORIC ACID POTASSIUM SORBATE WATER POLYSORBATE 20 HYDROGEN PEROXIDE HYDROGEN PEROXIDE SACCHARIN SODIUM SACCHARIN POLOXAMER 407 ALCOHOL Clean Mint
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 PerioRestore™ Oral Cleaning Gel Clean Mint 1.7% Hydrogen Peroxide Net Wt. 3 oz. (85 g) PM 5607.jpg
Principal Display Panel PerioRestor® Oral Cleansing Gel 1.7% Hydrogen Peroxide Net Wt. 3 oz. (85 g) Clean Mint NDC 59883-018-87 Perio_Restore_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. Children under 12 years of age should be supervised when using this product.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at a controlled room temperature, 25-25° C (68-77° F) and away from direct sunlight. For your protection, do not use if tamper seal on box is broken or missing.
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 Do not use Perio Restore Gel for more than 7 days unless directed by your dentist or physician. Stop use and ask your dentist or physician if: Symptoms of wounds or inflammation do not improve within 7 days. Irritation, pain or redness persists or worsens Swelling, rash or fever develops
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