Gly-Oxide

Manufacturer
Denison Pharmaceuticals LLC
Effective date
2018-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:33:15

Label at a glance#

ProductGly-Oxide
Active ingredientCARBAMIDE PEROXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 10% non USP*

*pH differs from USP specifications

Purposes

OTC - PURPOSE SECTION

Oral debriding agent

Oral wound cleanser

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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:

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

do not store above 77°F (25°C)

store bottle in the outer carton

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-866-844-2797 (English/Spanish) weekdays, or visit glyoxide.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gly-Oxide LIQUID

(Carbamide peroxide 10%) Non USP*

ANTISEPTIC ORAL CLEANSER

½ FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL Gly-Oxide LIQUID (Carbamide peroxide 10%) Non USP* ANTISEPTIC ORAL CLEANSER ½ FL OZ (15 mL)PRINCIPAL DISPLAY PANEL Gly-Oxide LIQUID (Carbamide peroxide 10%) Non USP* ANTISEPTIC ORAL CLEANSER ½ FL OZ (15 mL)

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-12260295-1226-44, 0295-1226-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7bd0bacc-8264-39e4-e053-2991aa0a2903894e2ab7-c5a7-40be-8b49-227364e699092018-11-29WarningsExact identifier
spl id: 7bd0bacc-8264-39e4-e053-2991aa0a2903
spl set id: 894e2ab7-c5a7-40be-8b49-227364e69909

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.