OROXID FORTE ORAL HYGIENE- hydrogen peroxide spray 
OROXID FORTE ORAL HYGIENE- hydrogen peroxide solution 
Innova Medical Group

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.

----------

Keep out of reach of children

Keep away from children Keep away from children

Storage and Handling

Store at Temperature of 5ºc to 25ºc

Protect from Direct sunlight

Storage

Warning

Avoid direct contact with eyesAvoid direct contact with eyes

Innovative Help With

Innovative help with Gingivits, 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

How 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

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

Purpose

Purpose

Active Ingredient

Hydrogen peroxide Ingredient

Inactive ingredient

deionized water Inactive ingredient

Indication and usage

Indication

Product Description

Description

Active Ingredient

Active Ingredient

Package Label

Main panel

Main panel

Package label princile Display

Package Main display

OROXID FORTE ORAL HYGIENE 
hydrogen peroxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81794-800
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.94 mL  in 2.94 mL
Inactive Ingredients
Ingredient NameStrength
COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
GINGER (UNII: C5529G5JPQ)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX)  
SPEARMINT (UNII: J7I2T6IV1N)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81794-800-30100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/21/2021
2NDC:81794-800-4050 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/21/2021
OROXID FORTE ORAL HYGIENE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81794-900
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.94 mL  in 2.94 mL
Inactive Ingredients
Ingredient NameStrength
COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
GINGER (UNII: C5529G5JPQ)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX)  
SPEARMINT (UNII: J7I2T6IV1N)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81794-900-70500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2021
2NDC:81794-900-60250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2021
3NDC:81794-900-50150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2021
4NDC:81794-900-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/21/2021
Labeler - Innova Medical Group (117663689)
Establishment
NameAddressID/FEIBusiness Operations
Innova Medical Group117663689label(81794-800, 81794-900)
Establishment
NameAddressID/FEIBusiness Operations
ENIKAM d.o.o.520197715manufacture(81794-800, 81794-900)

Revised: 7/2021
Document Id: c6f6b21f-0aa1-9f13-e053-2a95a90af646
Set id: bf5540ce-b648-dc06-e053-2995a90af00c
Version: 3
Effective Time: 20210712
 
Innova Medical Group