FDA Label for Periogel

View Indications, Usage & Precautions

Periogel Product Label

The following document was submitted to the FDA by the labeler of this product Qnt Anderson, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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.


Otc - Do Not Use



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


Otc - Stop Use



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.

Otc - Keep Out Of Reach Of Children



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)


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