PerioRestore

Manufacturer
DEN-MAT HOLDINGS, LLC.
Effective date
2023-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:37

Label at a glance#

ProductPerioRestore
Active ingredientHYDROGEN PEROXIDE
Label structure10 sections

Indications and 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 and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide

1.7% w/w

Purpose

OTC - PURPOSE SECTION

Wound Cleanser

Indications & Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 12 years of age should be supervised when using this product.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PerioRestore™

Oral Cleaning Gel

Clean Mint

1.7% Hydrogen Peroxide

Net Wt. 3 oz. (85 g)

PM 5607.jpgPM 5607.jpg

Principal Display Panel

PACKAGE LABEL.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.jpgPerio_Restore_image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1095271hydrogen peroxide 1.7 % Oral GelPSN3
1095271hydrogen peroxide 0.017 MG/MG Oral GelSCD3
1095271hydrogen peroxide 1.7 % Oral GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-018-87PerioRestore85 g in 1 TUBEGEL853
59883-018-87PerioRestore1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-018PERIORESTORE (HYDROGEN PEROXIDE) GEL [DEN-MAT HOLDINGS, LLC.]3Current NDC, Legacy NDC, 2 package rows20231216_97a07c36-1af8-a636-e053-2a95a90ad6db.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-01859883-018-87

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
ndc (package): 59883-018-87
ndc (product): 59883-018
ndc11 (package): 59883001887
spl id: 0a0d08d7-e3f3-d98d-e063-6394a90af5e9
spl set id: 97a07c36-1af8-a636-e053-2a95a90ad6db

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.