PERIORESTORE- hydrogen peroxide gel 
DEN-MAT HOLDINGS, LLC.

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PerioRestore

Active Ingredients

Hydrogen Peroxide

1.7% w/w

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:

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)

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

PERIORESTORE 
hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-018
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE17 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-018-871 in 1 BOX07/15/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/15/2019
Labeler - DEN-MAT HOLDINGS, LLC. (809857704)

Revised: 11/2023
Document Id: 0a0d08d7-e3f3-d98d-e063-6394a90af5e9
Set id: 97a07c36-1af8-a636-e053-2a95a90ad6db
Version: 3
Effective Time: 20231113
 
DEN-MAT HOLDINGS, LLC.