Label: GLY-OXIDE- carbamide peroxide liquid
- NDC Code(s): 63029-500-01, 63029-500-02
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 24, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purposes
-
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
- canker sores
- aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
- temporary use in cleansing:
- Warnings
-
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
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GLY-OXIDE
carbamide peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-500-01 1 in 1 CARTON 06/01/2012 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63029-500-02 1 in 1 CARTON 06/01/2012 2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/01/2012 Labeler - Medtech Products Inc. (122715688)
