Label: PERIORESTORE- hydrogen peroxide gel

  • NDC Code(s): 59883-018-87
  • Packager: DEN-MAT HOLDINGS, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

If you are a consumer or patient please visit this version.

  • 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:

    • 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)

    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

  • INGREDIENTS AND APPEARANCE
    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)