1. Home
  2. Labeler Index
  3. Medtech Products Inc.
  4. 63029-500
  5. Label Information: Gly-oxide

FDA Label for Gly-oxide

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR IF:
    6. KEEP OUT OF THE REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Gly-oxide Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 PANELGly-Oxide LIQUID(Carbamide peroxide 10%) Non USP*ANTISEPTIC ORAL CLEANSER½ FL OZ (15 mL) - gly oxide 01

PRINCIPAL DISPLAY PANELGly-Oxide LIQUID(Carbamide peroxide 10%) Non USP*ANTISEPTIC ORAL CLEANSER½ FL OZ (15 mL) - gly oxide 01


* Please review the disclaimer below.