Label: PERIO DAILY DEFENSE- hydrogen peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 30, 2022

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  • Active ingredient

    Hydrogen Peroxide 1.7% w/w

  • Purpose

    Wound Cleaner

  • 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 Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis.

  • Warnings

    Do not use Perio Daily Defense 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 section

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

  • Directions

    For children under 2 years of age, consult a dentist or physician.

    For adults and children 2 years of age or 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 at bedtime, or as directed by a dentist or physician.
  • Other Information

    Store at controlled room temperature, 20-25º C (68-77º 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.

  • Labeling

    Carton

  • INGREDIENTS AND APPEARANCE
    PERIO DAILY DEFENSE 
    hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-017
    Route of AdministrationTOPICAL
    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
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SORBITOL (UNII: 506T60A25R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT ((Clean Mint)) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-017-031 g in 1 TUBE; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/31/2022
    Labeler - Den-Mat Holdings, LLC (809857704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies, Inc.148312838manufacture(59883-017) , label(59883-017) , pack(59883-017)
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