Active Ingredients
Hydrogen Peroxide
1.7% w/w
Periorestore Gel
FDA Label NDC 59883-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Den-mat Holdings, Llc. for the product Periorestore (NDC 59883-018). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, indications & uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wound Cleanser
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.
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
Keep Out Of Reach Of Children.
Children under 12 years of age should be supervised when using this product.
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.
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.
Inactive Ingredients
Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water.
Principal Display Panel
PerioRestore™
Oral Cleaning Gel
Clean Mint
1.7% Hydrogen Peroxide
Net Wt. 3 oz. (85 g)
PerioRestore™
Oral Cleansing Gel
1.7% Hydrogen Peroxide
Net Wt. 3 oz. (85 g) Clean Mint
* Please review the disclaimer below.
