GLY-OXIDE- carbamide peroxide liquid

Gly-Oxide by

Drug Labeling and Warnings

Gly-Oxide by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

GLY-OXIDE 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1226
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1226-44	1 in 1 CARTON	01/01/2017
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0295-1226-34	1 in 1 CARTON	01/01/2017
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2017

Labeler - Denison Pharmaceuticals LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals LLC		001207208	manufacture(0295-1226)