Your browser does not support JavaScript! PERIOGEL (HYDROGEN PEROXIDE) GEL [QNT ANDERSON, LLC]
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RxNorm Names

PERIOGEL (hydrogen peroxide) gel
[QNT Anderson, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PERIOGEL 
hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:75908-017
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrogen peroxide (hydrogen peroxide) hydrogen peroxide17 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
alcohol50 mg  in 1 g
menthol 
methyl salicylate 
phosphoric acid 
poloxamer 407 
polysorbate 20 
potassium sorbate 
saccharin sodium 
sorbitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75908-017-851 in 1 CARTON
185 g in 1 TUBE
2NDC:75908-017-281 in 1 CARTON
228.3 g in 1 TUBE
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

Revised: 9/2011
 
QNT Anderson, LLC

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