Periogel®

Periogel®
SPL v4
SPL
SPL Set ID 30f97d9b-7551-499f-b3bb-5a658bd3a493
Route
DENTAL
Published
Effective Date 2022-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (17 mg)
Inactive Ingredients
Alcohol Menthol, Unspecified Form Methyl Salicylate Phosphoric Acid Poloxamer 407 Polysorbate 20 Potassium Sorbate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-04-01

Description

Drug Facts

Purpose

Oral Debriding Agent/Oral Wound Cleanser


Medication Information

Purpose

Oral Debriding Agent/Oral Wound Cleanser

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.
Section 50570-1

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

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.

Active Ingredient

Hydrogen peroxide 1.7% (w/w)

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

Perio gel ®

Oral Debriding Agent /

Oral Wound Cleanser


(Hydrogen Peroxide)

NET WT. 3 OZ. (85 g)

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.

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.
Section 50570-1 (50570-1)

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

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.

Active Ingredient (Active ingredient)

Hydrogen peroxide 1.7% (w/w)

Other Information (Other information)

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

Inactive Ingredients (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? (Questions or comments?)

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

Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Perio gel ®

Oral Debriding Agent /

Oral Wound Cleanser


(Hydrogen Peroxide)

NET WT. 3 OZ. (85 g)

Directions for Adults and Children 2 Years of Age and Older (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.

Advanced Ingredient Data


Raw Label Data

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