Label: ORAL PEROXIDE- carbamide peroxide liquid 

  • Label RSS
  • 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 08/12

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

  • Active ingredient

    Carbamide peroxide 10%

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  • Purposes

    Oral debriding agent

    Oral wound cleanser

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  • Uses

    • temporary use in cleansing:
      • canker sore
      • minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
    • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
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  • Warnings

    Do not use

    this product for more than 7 days unless directed by a dentist or doctor.

    When using this product:

    • do not swallow
    • avoid contact with eyes

    Stop use and ask a doctor if:

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

    Keep out of the reach of children.

    If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • unscrew cap and remove safety seal from bottle
    • affix applicator cap to bottle
    • replace top of bottle when not in use

    Adults and children 2 years and older:

    • use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor

    For direct application

    • do not dilute
    • apply several drops directly from bottle onto affected area
    • spit out after 2 to 3 minutes

    As a mouthwash (oral rinse)

    • place 10 to 20 drops onto tongue
    • mix with saliva
    • swish around in the mouth over the affected area for at least 1 minute and spit out

    Children under 12 years: should be supervised in the use of this product

    Children under 2 years: consult a dentist or doctor

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  • Other information

    • protect from excessive heat and direct sunlight
    • store bottle in the outer carton
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  • Inactive ingredients

    citric acid, flavor - mint, flavor - cinnamon, glycerin, propylene glycol, sodium lauroyl sarcosinate, sodium stannate, water

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  • Questions or comments?

    call toll-free 1-800-616-2471

    GLY-OXIDE is a registered trademark of Aventisub II Inc. licensed to the GlaxoSmithKline group of companies.

    Distributed by:

    Major Pharmaceuticals

    Livonia, MI 48150 USA

    Read and retain carton for full product information.

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  • Principal Display Panel

    NDC 0904-4062-03

    Oral Peroxide

    (Carbamide Peroxide 10%)

    ANTISEPTIC ORAL CLEANSER

    For minor mouth or gum irritations

    Recommended by Doctors and Dentists

    • Cleanses dental appliance irritations
    • Soothes canker sores
    • Kills odor-forming germs

    2 fl oz (60 ml)

    Oral Peroxide

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  • INGREDIENTS AND APPEARANCE
    ORAL PEROXIDE 
    carbamide peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-4062
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE 0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    PROPYLENE GLYCOL  
    SODIUM LAUROYL SARCOSINATE  
    SODIUM STANNATE  
    WATER  
    MINT  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-4062-03 1 in 1 CARTON
    1 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 11/25/2011
    Labeler - Major Pharmaceuticals (191427277)
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