Oral Peroxide description, usages, side effects, indications, overdosage, supplying and lots more!

Oral Peroxide

Major Pharmaceuticals

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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)

Principal Display Panel

Oral Peroxide

carbamide peroxide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-4062
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 0.1 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
SODIUM LAUROYL SARCOSINATE
SODIUM STANNATE
water
MINT

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:0904-4062-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-11-25


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.