GLY-OXIDE- carbamide peroxide liquid 
Denison Pharmaceuticals LLC

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

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

  • replace tip on 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

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:0295-1226
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.1 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)  
SODIUM STANNATE (UNII: NJ7C1V83KG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1226-441 in 1 CARTON01/01/2017
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0295-1226-341 in 1 CARTON01/01/2017
215 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 finalpart35601/01/2017
Labeler - Denison Pharmaceuticals LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals LLC001207208manufacture(0295-1226)

Revised: 11/2018
 
Denison Pharmaceuticals LLC