FDA.reportPublic FDA data

OROXID Forte Oral Hygiene

Manufacturer
Innova Medical Group | ENIKAM d.o.o.
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:32

Label at a glance#

ProductOROXID Forte Oral Hygiene
Active ingredientHYDROGEN PEROXIDE
Label structure14 sections

Storage and handling

Store at Temperature of 5ºc to 25ºc Protect from Direct sunlight

Label contents#

Full prescribing information#

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from children Keep away from childrenKeep away from children

Storage and Handling

STORAGE AND HANDLING SECTION

Store at Temperature of 5ºc to 25ºc

Protect from Direct sunlight

StorageStorage

Warning

WARNINGS SECTION

Avoid direct contact with eyesAvoid direct contact with eyesAvoid direct contact with eyes

Innovative Help With

OTC - WHEN USING SECTION

Innovative help withInnovative help withGingivits, Periodontitis

Inflammation of oral cavity

Bleeding and irritated gums

Intensive oral hygiene(Fixed dental braces, prosthesis, implants)

Reduction of deposit on the tongue

Prevention of dental plaque

Reduction of tooth stains

Restoration of fresh breath

How to use

DESCRIPTION SECTION

How to useHow to useUse OROXID Forte two to three times a day prederably during or after brushing your teech. Spray the solution into the oral cavity with 3 to 4 pressures of the spray, gargle for about 30 seconds and spit it out. Use OROXID forte reqularly, until the situation of elimincation of inflammation immproves.

Dosage Administrationt

DOSAGE & ADMINISTRATION SECTION

3 to 4 pressure of the spray, two to three times a day DosageDosage

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide IngredientIngredient

Inactive ingredient

INACTIVE INGREDIENT SECTION

deionized water Inactive ingredientInactive ingredient

Indication and usage

INDICATIONS & USAGE SECTION

IndicationIndication

Product Description

DESCRIPTION SECTION

DescriptionDescription

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Main panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main panelMain panel

Package label princile Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Main displayPackage Main display

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81794-800-30OROXID Forte Oral Hygiene100 mL in 1 BOTTLE, SPRAYSPRAY1003
81794-800-40OROXID Forte Oral Hygiene50 mL in 1 BOTTLE, SPRAYSPRAY503
81794-900-30OROXID Forte Oral Hygiene30 mL in 1 BOTTLESOLUTION303
81794-900-50OROXID Forte Oral Hygiene150 mL in 1 BOTTLESOLUTION1503
81794-900-60OROXID Forte Oral Hygiene250 mL in 1 BOTTLESOLUTION2503
81794-900-70OROXID Forte Oral Hygiene500 mL in 1 BOTTLESOLUTION5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81794-800OROXID FORTE ORAL HYGIENE (HYDROGEN PEROXIDE) SPRAY OROXID FORTE ORAL HYGIENE (HYDROGEN PEROXIDE) SOLUTION [INNOVA MEDICAL GROUP]3Legacy NDC, 2 package rows20210717_bf5540ce-b648-dc06-e053-2995a90af00c.zip
81794-900OROXID FORTE ORAL HYGIENE (HYDROGEN PEROXIDE) SPRAY OROXID FORTE ORAL HYGIENE (HYDROGEN PEROXIDE) SOLUTION [INNOVA MEDICAL GROUP]3Legacy NDC, 4 package rows20210717_bf5540ce-b648-dc06-e053-2995a90af00c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81794-80081794-800-30, 81794-800-40
81794-90081794-900-70, 81794-900-60, 81794-900-50, 81794-900-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
COMMIPHORA MYRRHA STEM BARKI4FHO0W8V5IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
GINGERC5529G5JPQIACT
ECHINACEA PURPUREAQI7G114Y98IACT
STEVIA EUPATORIA WHOLED0Y0869IHXIACT
SPEARMINTJ7I2T6IV1NIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
COMMIPHORA MYRRHA STEM BARKI4FHO0W8V5IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
GINGERC5529G5JPQIACT
ECHINACEA PURPUREAQI7G114Y98IACT
STEVIA EUPATORIA WHOLED0Y0869IHXIACT
SPEARMINTJ7I2T6IV1NIACT
PEG-40 CASTOR OIL4ERD2076EFIACT

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
c6f6b21f-0aa1-9f13-e053-2a95a90af646bf5540ce-b648-dc06-e053-2995a90af00c2021-07-12WarningsExact identifier
spl id: c6f6b21f-0aa1-9f13-e053-2a95a90af646
spl set id: bf5540ce-b648-dc06-e053-2995a90af00c

Reported adverse events (FAERS/openFDA)#

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