FDA.reportPublic FDA data

Gly-Oxide

Manufacturer
Medtech Products Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:31:49

Label at a glance#

ProductGly-Oxide
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

Indications and 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

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 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...

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 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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 (1-800-222-1222) 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 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

Other information

OTHER SAFETY INFORMATION

  • do not store above 25°C (77°F )
  • store bottle in the outer carton

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-866-255-5202 weekdays

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gly-Oxide LIQUID
(Carbamide peroxide 10%) Non USP*
ANTISEPTIC ORAL CLEANSER
2FL OZ (60 mL)

PRINCIPAL DISPLAY PANEL Gly-Oxide LIQUID (Carbamide peroxide 10%) Non USP* ANTISEPTIC ORAL CLEANSER 2FL OZ (60 mL)PRINCIPAL DISPLAY PANEL Gly-Oxide LIQUID (Carbamide peroxide 10%) Non USP* ANTISEPTIC ORAL CLEANSER 2FL OZ (60 mL)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL Gly-Oxide LIQUID (Carbamide peroxide 10%) Non USP* ANTISEPTIC ORAL CLEANSER 0.5 FL OZ (15 mL)PRINCIPAL DISPLAY PANEL Gly-Oxide LIQUID (Carbamide peroxide 10%) Non USP* ANTISEPTIC ORAL CLEANSER 0.5 FL OZ (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582808carbamide peroxide 10 % Mucous Membrane Topical SolutionPSN7
1048144Gly-Oxide Oral Cleanser 10 % Mucous Membrane Topical SolutionPSN7
1048144carbamide peroxide 100 MG/ML Mucous Membrane Topical Solution [Gly-Oxide]SBD7
582808carbamide peroxide 100 MG/ML Mucous Membrane Topical SolutionSCD7
582808carbamide peroxide 10 % Mucous Membrane Topical SolutionSY7
1048144Gly-Oxide 100 MG/ML Mucous Membrane Topical SolutionSY7
1048144Glyoxide 10 % Mucous Membrane Topical SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-500-01Gly-Oxide15 mL in 1 BOTTLELIQUID157
63029-500-01Gly-Oxide1 in 1 CARTONLIQUID17
63029-500-02Gly-Oxide1 in 1 CARTONLIQUID17
63029-500-02Gly-Oxide60 mL in 1 BOTTLELIQUID607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-500GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]7Current NDC, Legacy NDC, 4 package rows20241101_086a0b82-e947-41c9-89e7-ba06483960c9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-500-01ML - Milliliter63029-50072518b1d-ed1c-4cff-9d58-fb4d6f0b19e212015-06-09
63029-500-02ML - Milliliter63029-500c14abdc4-5469-4ed1-b6c3-f1bb27eb6c9912015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU812
CARBAMIDE PEROXIDEACTIVE MOIETY31PZ2VAU812
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS996182
SODIUM STANNATEINACTIVE INGREDIENTNJ7C1V83KG2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-50063029-500-01, 63029-500-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618SHAMPOO / TOPICAL12.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618SHAMPOO / TOPICAL12.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618SHAMPOO / TOPICAL12.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618LOTION / TOPICAL70 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618LOTION / TOPICAL70 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618LOTION / TOPICAL70 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
ndc (package): 63029-500-01
ndc (package): 63029-500-02
ndc (product): 63029-500
ndc11 (package): 63029050002
ndc11 (package): 63029050001
spl id: 4c198ce8-ecfe-4ea1-99b7-fcc65f6346b8
spl set id: 086a0b82-e947-41c9-89e7-ba06483960c9

Reported adverse events (FAERS/openFDA)#

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