FDA.reportPublic FDA data

OROXID Sensitiv

Manufacturer
Innova Medical Group | ENIKAM d.o.o.
Effective date
2021-07-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:40

Label at a glance#

ProductOROXID Sensitiv
Active ingredientHYDROGEN PEROXIDE
Label structure13 sections

Storage and handling

Store at temperature of 5 °C to 25 °C

Label contents#

Full prescribing information#

Instruction For use

INSTRUCTIONS FOR USE SECTION

Use OROXID® sensitiv two to three times a day preferably during or
after brushing your teeth. Pour approximately 20 ml of liquid (content
of two cups) into a glass, gargle for about 30 seconds and spit it out
afterwards. OROXID® sensitiv is suitable for a long-term use.

OTC Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

hydrogen peroxide

Storage and handling

STORAGE AND HANDLING SECTION

storage and handlingstorage and handling

Description

DESCRIPTION SECTION

DescriptionDescription

Inactive Ingredient

INACTIVE INGREDIENT SECTION

deionized water,
Actipone® PX3, fl avors, stabilizer.

Storage

STORAGE AND HANDLING SECTION

Store at temperature
of 5 °C to 25 °C

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

DosageDosage

Warning

WARNINGS SECTION

WarningWarning

Indicationg

INDICATIONS & USAGE SECTION

Indication and usageIndication and usage

Keep reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from Children

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main panelMain panel

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81794-600-30OROXID Sensitiv30 mL in 1 BOTTLESOLUTION302
81794-600-50OROXID Sensitiv150 mL in 1 BOTTLESOLUTION1502
81794-600-60OROXID Sensitiv250 mL in 1 BOTTLESOLUTION2502
81794-600-70OROXID Sensitiv500 mL in 1 BOTTLESOLUTION5002
81794-700-30OROXID Sensitiv100 mL in 1 BOTTLE, SPRAYSPRAY1002
81794-700-40OROXID Sensitiv50 mL in 1 BOTTLE, SPRAYSPRAY502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81794-600OROXID SENSITIV (HYDROGEN PEROXIDE) SOLUTION OROXID SENSITIV (HYDROGEN PEROXIDE) SPRAY [INNOVA MEDICAL GROUP]2Legacy NDC, 4 package rows20210726_c6559121-75dd-2e86-e053-2995a90abade.zip
81794-700OROXID SENSITIV (HYDROGEN PEROXIDE) SOLUTION OROXID SENSITIV (HYDROGEN PEROXIDE) SPRAY [INNOVA MEDICAL GROUP]2Legacy NDC, 2 package rows20210726_c6559121-75dd-2e86-e053-2995a90abade.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81794-60081794-600-70, 81794-600-50, 81794-600-30, 81794-600-60
81794-70081794-700-30, 81794-700-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
GINGERC5529G5JPQIACT
ECHINACEA PURPUREA WHOLEQI7G114Y98IACT
COMMIPHORA MYRRHA STEM BARKI4FHO0W8V5IACT
PEG-40 CASTOR OIL4ERD2076EFIACT
SPEARMINTJ7I2T6IV1NIACT
WATER059QF0KO0RIACT
STEVIA EUPATORIA WHOLED0Y0869IHXIACT
SPEARMINTJ7I2T6IV1NIACT
GINGERC5529G5JPQIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
WATER059QF0KO0RIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
ECHINACEA PURPUREA WHOLEQI7G114Y98IACT
COMMIPHORA MYRRHA STEM BARKI4FHO0W8V5IACT
STEVIA EUPATORIA WHOLED0Y0869IHXIACT

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
c7e3d87f-abb2-07e9-e053-2995a90aa6aac6559121-75dd-2e86-e053-2995a90abade2021-07-24WarningsExact identifier
spl id: c7e3d87f-abb2-07e9-e053-2995a90aa6aa
spl set id: c6559121-75dd-2e86-e053-2995a90abade

Reported adverse events (FAERS/openFDA)#

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