Label: PERIOGEL- hydrogen peroxide gel 

  • Label RSS
  • NDC Code(s): 75908-017-28, 75908-017-85
  • Packager: QNT Anderson, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Hydrogen peroxide 1.7% (w/w)

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  • Purpose

    Oral Debriding Agent/Oral Wound Cleanser

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  • Approved Uses

    For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

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  • Warnings

    Do not use for more than 7 days unless directed by a dentist or doctor. Spit out excess medication.

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens;
    • swelling, rash or fever develops.

    Keep out of reach of children.

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  • Directions for adults and children 2 years of age and older

    • Apply several drops to the affected area of the mouth.
    • Allow medication to remain in place at least 1 minute and then spit out.
    • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 2 years of age:
      Consult a dentist or doctor.
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  • Other information

    Store at controlled room temperature (68°-77°F) in a cool, dry place away from direct sunlight.

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  • Inactive ingredients

    Inactive ingredients: ethyl alcohol (5% w/w), menthol, methyl salicylate, phosphoric acid, poloxamer 407, polysorbate 20, potassium sorbate, sodium saccharin, sorbitol, water.

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  • Questions or comments?

    Call toll free 1-877-907-3746 from 9am - 5pm CST/CDT Monday-Friday.

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  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    Periogel®

    Oral Debriding Agent /
    Oral Wound Cleanser

    (Hydrogen Peroxide)

    NET WT. 3 OZ. (85 g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    PERIOGEL 
    hydrogen peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:75908-017
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    hydrogen peroxide (hydrogen peroxide) hydrogen peroxide 17 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    alcohol 50 mg  in 1 g
    menthol  
    methyl salicylate  
    phosphoric acid  
    poloxamer 407  
    polysorbate 20  
    potassium sorbate  
    saccharin sodium  
    sorbitol  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor WINTERGREEN Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75908-017-85 1 in 1 CARTON
    1 85 g in 1 TUBE
    2 NDC:75908-017-28 1 in 1 CARTON
    2 28.3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 04/01/2011
    Labeler - QNT Anderson, LLC (962173030)
    Establishment
    Name Address ID/FEI Business Operations
    Unicep Packaging, Inc. 790263909 MANUFACTURE
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