PERIOGEL- hydrogen peroxide gel 
QNT Anderson, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Periogel®

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

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
PERIOGEL 
hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75908-017
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V) hydrogen peroxide17 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75908-017-851 in 1 CARTON04/01/2011
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:75908-017-281 in 1 CARTON04/01/2011
228.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2011
Labeler - QNT Anderson, LLC (962173030)
Establishment
NameAddressID/FEIBusiness Operations
Unicep Packaging, Inc.790263909MANUFACTURE(75908-017)

Revised: 5/2022
Document Id: 4539ba00-922d-473d-8c61-2fa0c3ef5e97
Set id: 30f97d9b-7551-499f-b3bb-5a658bd3a493
Version: 4
Effective Time: 20220513
 
QNT Anderson, LLC