GLY-OXIDE - carbamide peroxide liquid 
Medtech Products Inc.

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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Drug Facts

Active ingredient

Carbamide peroxide 10% non USP*

*pH differs from USP specifications

Purposes

Oral debriding agent

Oral wound cleanser

Uses

temporary use in cleansing:

Warnings

Do not use this product for more than 7 days unless directed by a dentist or doctor.

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

Adults and children 2 years and older:

For direct application

As a mouthwash (oral rinse)

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

Children under 2 years: consult a dentist or doctor

Other information

do not store above 77°F (25°C)

store bottle in the outer carton

Inactive ingredients

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

Questions or comments?

call toll-free 1-866-844-2797 (English/Spanish) weekdays, or visit glyoxide.com





PRINCIPAL DISPLAY PANEL

Gly-Oxide LIQUID
(Carbamide peroxide 10%) Non USP*
ANTISEPTIC ORAL CLEANSER
½ FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL
Gly-Oxide LIQUID
(Carbamide peroxide 10%) Non USP*
ANTISEPTIC ORAL CLEANSER
½ FL OZ (15 mL)


GLY-OXIDE 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE) CARBAMIDE PEROXIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM LAUROYL SARCOSINATE 
SODIUM STANNATE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63029-500-011 BOTTLE (1 BOTTLE) in 1 CARTONcontains a BOTTLE
115 mL in 1 BOTTLEThis package is contained within the CARTON (63029-500-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/01/2012

Labeler - Medtech Products Inc. (122715688)

Revised: 06/2012 Medtech Products Inc.