Gly-oxide Liquid
FDA Label NDC 63029-500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Gly-oxide (NDC 63029-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, warnings, stop use and ask a doctor if:, keep out of the reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.