PERIOGEL- hydrogen peroxide gel

Periogel by

Drug Labeling and Warnings

Periogel by is a Otc medication manufactured, distributed, or labeled by QNT Anderson, LLC, Unicep Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

PERIOGEL 
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75908-017
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V)	hydrogen peroxide	17 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75908-017-85	1 in 1 CARTON	04/01/2011
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75908-017-28	1 in 1 CARTON	04/01/2011
2		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/01/2011

Labeler - QNT Anderson, LLC (962173030)

Establishment
Name	Address	ID/FEI	Business Operations
Unicep Packaging, Inc.		790263909	MANUFACTURE(75908-017)