OROXID SENSITIV- hydrogen peroxide solution 
OROXID SENSITIV- hydrogen peroxide spray 
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.

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Instruction For use

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

hydrogen peroxide

Storage and handling

storage and handling

Description

Description

Inactive Ingredient

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

Storage

Store at temperature
of 5 °C to 25 °C

Dosage and administration

Dosage

Warning

Warning

Indicationg

Indication and usage

Keep reach of Children

Keep away from Children

Purpose

Purpose

Package

Main panel

Package Label

Label

OROXID SENSITIV 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81794-600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 mL  in 1.5 mL
Inactive Ingredients
Ingredient NameStrength
GINGER (UNII: C5529G5JPQ)  
ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)  
COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
SPEARMINT (UNII: J7I2T6IV1N)  
WATER (UNII: 059QF0KO0R)  
STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81794-600-70500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2021
2NDC:81794-600-50150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2021
3NDC:81794-600-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2021
4NDC:81794-600-60250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/12/2021
OROXID SENSITIV 
hydrogen peroxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81794-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 mL  in 1.5 mL
Inactive Ingredients
Ingredient NameStrength
SPEARMINT (UNII: J7I2T6IV1N)  
GINGER (UNII: C5529G5JPQ)  
WATER (UNII: 059QF0KO0R)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)  
COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5)  
STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81794-700-30100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/12/2021
2NDC:81794-700-4050 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/12/2021
Labeler - Innova Medical Group (117663689)
Establishment
NameAddressID/FEIBusiness Operations
Innova Medical Group117663689label(81794-600, 81794-700)
Establishment
NameAddressID/FEIBusiness Operations
ENIKAM d.o.o.520197715manufacture(81794-600, 81794-700)

Revised: 7/2021
Document Id: c7e3d87f-abb2-07e9-e053-2995a90aa6aa
Set id: c6559121-75dd-2e86-e053-2995a90abade
Version: 2
Effective Time: 20210724
 
Innova Medical Group