PerioRestore
PerioRestore is an FDA drug label for the active ingredient HYDROGEN PEROXIDE manufactured by DEN-MAT HOLDINGS, LLC. administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231113.
Generic: HYDROGEN PEROXIDE
Manufacturer: DEN-MAT HOLDINGS, LLC.
Product Type: HUMAN OTC DRUG
Route: DENTAL
Dosage Form:
NDC: 59883-018
Application: M022
Effective: 20231113
Active Ingredients: Active Ingredients Hydrogen Peroxide 1.7% w/w
Indications & Usage
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.
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.
Contraindications
Not available.
Warnings
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
Adverse Reactions
Not available.
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