Label: PERIOGEL- 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 May 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrogen peroxide 1.7% (w/w)

  • Purpose

    Oral Debriding Agent/Oral Wound Cleanser

  • 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.

  • 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.

  • 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.
  • Other information

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

  • Inactive ingredients

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

  • Questions or comments?

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

  • 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
  • INGREDIENTS AND APPEARANCE
    PERIOGEL 
    hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75908-017
    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
    alcohol (UNII: 3K9958V90M) 50 mg  in 1 g
    menthol, unspecified form (UNII: L7T10EIP3A)  
    methyl salicylate (UNII: LAV5U5022Y)  
    phosphoric acid (UNII: E4GA8884NN)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75908-017-851 in 1 CARTON04/01/2011
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75908-017-281 in 1 CARTON04/01/2011
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/01/2011
    Labeler - QNT Anderson, LLC (962173030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unicep Packaging, Inc.790263909MANUFACTURE(75908-017)
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