PerioRestore

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HYDROGEN PEROXIDE
PerioRestore

PerioRestore HYDROGEN PEROXIDE DEN-MAT HOLDINGS, LLC. FDA Approved 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.

Generic: HYDROGEN PEROXIDE

Mfr: DEN-MAT HOLDINGS, LLC. FDA OTC

Substance Hydrogen Peroxide

Route

DENTAL

Applications

M022

Product NDC

59883-0018-00 59883-0018-87

Package NDC

59883-018-87

Drug Facts

Composition & Profile

Active Ingredients

Active Ingredients Hydrogen Peroxide 1.7% w/w

Inactive Ingredients

Inactive Ingredients Ethyl Alcohol Menthol Methyl Salicylate Phosphoric Acid Poloxamer 407 Polysorbate 20 Potassium Sorbate Sodium Saccharin Sorbitol Water.

Strengths

1.7 %

Treats Conditions

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

Identifiers & Packaging

Container Type UNKNOWN

NDC 59883-0018-00

All Product Codes

59883-0018-00 59883-0018-87

UNII

BBX060AN9V

SPL Set IDs

97a07c36-1af8-a636-e053-2a95a90ad6db

Packaging

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

Package Descriptions

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

Overview

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.

Indications & Usage

Dosage & Administration

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.

Warnings & Precautions

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

Purpose

Purpose Wound Cleanser

Keep Out of Reach of Children

Keep out of reach of children. Children under 12 years of age should be supervised when using this product.