Your browser does not support JavaScript! ORAL PEROXIDE (CARBAMIDE PEROXIDE) LIQUID [MAJOR PHARMACEUTICALS]
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ORAL PEROXIDE (carbamide peroxide) liquid
[Major Pharmaceuticals]


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

Active ingredient

Carbamide peroxide 10%

Purposes

Oral debriding agent

Oral wound cleanser

Uses

  • temporary use in cleansing:
    • canker sore
    • minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
  • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

Do not use

this product for more than 7 days unless directed by a dentist or doctor.

When using this product:

  • do not swallow
  • avoid contact with eyes

Stop use and ask a doctor if:

  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

Keep out of the reach of children.

If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • unscrew cap and remove safety seal from bottle
  • affix applicator cap to bottle
  • replace top of bottle when not in use

Adults and children 2 years and older:

  • use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor

For direct application

  • do not dilute
  • apply several drops directly from bottle onto affected area
  • spit out after 2 to 3 minutes

As a mouthwash (oral rinse)

  • place 10 to 20 drops onto tongue
  • mix with saliva
  • swish around in the mouth over the affected area for at least 1 minute and spit out

Children under 12 years: should be supervised in the use of this product

Children under 2 years: consult a dentist or doctor

Other information

  • protect from excessive heat and direct sunlight
  • store bottle in the outer carton

Inactive ingredients

citric acid, flavor - mint, flavor - cinnamon, glycerin, propylene glycol, sodium lauroyl sarcosinate, sodium stannate, water

Questions or comments?

call toll-free 1-800-616-2471

GLY-OXIDE is a registered trademark of Aventisub II Inc. licensed to the GlaxoSmithKline group of companies.

Distributed by:

Major Pharmaceuticals

Livonia, MI 48150 USA

Read and retain carton for full product information.

Principal Display Panel

NDC 0904-4062-03

Oral Peroxide

(Carbamide Peroxide 10%)

ANTISEPTIC ORAL CLEANSER

For minor mouth or gum irritations

Recommended by Doctors and Dentists

  • Cleanses dental appliance irritations
  • Soothes canker sores
  • Kills odor-forming germs

2 fl oz (60 ml)

Oral Peroxide

ORAL PEROXIDE 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-4062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM LAUROYL SARCOSINATE 
SODIUM STANNATE 
WATER 
MINT 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-4062-031 in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35611/25/2011
Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2012
 
Major Pharmaceuticals

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