GLY-OXIDE - carbamide peroxide liquid
GlaxoSmithKline Consumer Healthcare LP

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.

----------

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

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 essentialsforlivingwell.com

NOTE: Oversize package for ease in reading label information. Contains one bottle.

GLY-OXIDE is a registerd trademark of Aventisub II Inc. licensed to the GlaxoSmithKline group of companies.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Read and retain carton for full product information.

IMPORTANT: This package has been overwrapped for your protection. Do not use if plastic overwrap printed “SEALED for YOUR PROTECTION” is disturbed or missing.

Principal Display Panel

NDC 0135-0099-65

Gly-Oxide®

Liquid

(Carbamide Peroxide 10%)

Non USP

Antiseptic Oral Cleanser

For minor mouth or gum irritations

NEW LOOK!

Recommended by Doctors and Dentists

Cleanses dental appliance irritations
Soothes canker sores
Kills odor-forming germs

Oxygen-rich Microfoam Action

2 fl oz (60 ml)

28641XD

Gly-Oxide 2 fl oz (60 mL) carton

GLY-OXIDE
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0099
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE)	CARBAMIDE PEROXIDE	0.1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
SODIUM LAUROYL SARCOSINATE
SODIUM STANNATE
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0099-65	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		60 mL in 1 BOTTLE	This package is contained within the CARTON (0135-0099-65)
2	NDC:0135-0099-63	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		15 mL in 1 BOTTLE	This package is contained within the CARTON (0135-0099-63)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/08/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 10/2011 GlaxoSmithKline Consumer Healthcare LP