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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Gly-Oxide

Drug Facts

Active ingredient

Carbamide peroxide 10% non USP*

*pH differs from USP specifications

Purposes

Oral debriding agent

Oral wound cleanser

Uses

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 (1-800-222-1222) 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

Inactive ingredients

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

Questions?

1-866-255-5202 weekdays





PRINCIPAL DISPLAY PANEL

Gly-Oxide LIQUID
(Carbamide peroxide 10%) Non USP*
ANTISEPTIC ORAL CLEANSER
2FL OZ (60 mL)

PRINCIPAL DISPLAY PANEL
Gly-Oxide LIQUID
(Carbamide peroxide 10%) Non USP*
ANTISEPTIC ORAL CLEANSER
2FL OZ (60 mL)

PRINCIPAL DISPLAY PANEL

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

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

GLY-OXIDE 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-500-011 in 1 CARTON06/01/2012
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63029-500-021 in 1 CARTON06/01/2012
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 7/2023
Document Id: b03e7dd0-f18c-42a3-929f-8c69974f4c24
Set id: 086a0b82-e947-41c9-89e7-ba06483960c9
Version: 6
Effective Time: 20230724
 
Medtech Products Inc.