Drugplain

PerioRestore 17 mg/g

Hydrogen Peroxide · GEL · DEN-MAT HOLDINGS, LLC.

No Recall History
Plain English

PerioRestore is a gel containing hydrogen peroxide at 17 mg/g, taken dental. Manufactured by DEN-MAT HOLDINGS, LLC..

Key Facts

Brand Name
PerioRestore
Generic Name
Hydrogen Peroxide
NDC Code (Product)
59883-018
Manufacturer
DEN-MAT HOLDINGS, LLC.
Strength
17 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Marketing Start
07/15/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective37 reports
nausea23 reports
fatigue22 reports
vomiting17 reports
headache16 reports
rash16 reports
product use in unapproved indication15 reports
pruritus14 reports
shock haemorrhagic14 reports
gastritis erosive13 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

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

Frequently Asked Questions

What is PerioRestore used for?

PerioRestore contains Hydrogen Peroxide. It is a gel taken dental. Consult your doctor for specific uses.

Is PerioRestore a controlled substance?

PerioRestore is not classified as a controlled substance by the DEA.

What is the generic name for PerioRestore?

The generic name for PerioRestore is Hydrogen Peroxide. There are 12 other brand versions of Hydrogen Peroxide.

What is the NDC code for PerioRestore 17 mg/g?

The NDC (National Drug Code) for PerioRestore 17 mg/g is 59883-018, listed by DEN-MAT HOLDINGS, LLC..

Product NDC

59883-018

Package NDC

59883-018-87

Other Hydrogen Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)