Periogel
FDA Label NDC 75908-017

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Qnt Anderson, Llc for the product Periogel (NDC 75908-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, approved uses, otc - do not use, otc - stop use, otc - keep out of reach of children, directions for adults and children 2 years of age and older, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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)

Principal Display Panel (85 g Tube Carton)

Principal Display Panel (85 g Tube Carton)

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