Gly-oxide

Gly-oxide
SPL v7
SPL
SPL Set ID 086a0b82-e947-41c9-89e7-ba06483960c9
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01

Description

Drug Facts

Purpose

Oral debriding agent Oral wound cleanser


Medication Information

Purpose

Oral debriding agent Oral wound cleanser

Description

Drug Facts

Uses
  • temporary use in cleansing:
    • canker sores

    • 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
Do Not

this product for more than 7 days unless directed by a dentist or doctor.

Section 42229-5

Drug Facts

Section 51945-4

Gly-Oxide LIQUID

(Carbamide peroxide 10%) Non USP*

ANTISEPTIC ORAL CLEANSER

2FL OZ (60 mL)

Purposes

Oral debriding agent

Oral wound cleanser

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 a dentist or doctor

For direct application

  • do not dilute

  • apply several drops directly from the 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

Questions?

1-866-255-5202 weekdays

Active Ingredient

Carbamide peroxide 10% non USP*

*pH differs from USP specifications

Other Information
  • do not store above 25°C (77°F )

  • store bottle in the outer carton
Inactive Ingredients

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

Principal Display Panel

Gly-Oxide LIQUID

(Carbamide peroxide 10%) Non USP*

ANTISEPTIC ORAL CLEANSER

0.5 FL OZ (15 mL)

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.


Structured Label Content

Uses
  • temporary use in cleansing:
    • canker sores

    • 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
Do Not (Do not)

this product for more than 7 days unless directed by a dentist or doctor.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Gly-Oxide LIQUID

(Carbamide peroxide 10%) Non USP*

ANTISEPTIC ORAL CLEANSER

2FL OZ (60 mL)

Purposes

Oral debriding agent

Oral wound cleanser

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 a dentist or doctor

For direct application

  • do not dilute

  • apply several drops directly from the 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

Questions?

1-866-255-5202 weekdays

Active Ingredient (Active ingredient)

Carbamide peroxide 10% non USP*

*pH differs from USP specifications

Other Information (Other information)
  • do not store above 25°C (77°F )

  • store bottle in the outer carton
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Gly-Oxide LIQUID

(Carbamide peroxide 10%) Non USP*

ANTISEPTIC ORAL CLEANSER

0.5 FL OZ (15 mL)

When Using This Product (When using this product)
  • do not swallow

  • avoid contact with eyes
Stop Use and Ask A Doctor If: (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. (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.


Advanced Ingredient Data


Raw Label Data

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