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

OROXID Sensitiv by

Drug Labeling and Warnings

OROXID Sensitiv by is a Otc medication manufactured, distributed, or labeled by Innova Medical Group, ENIKAM d.o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Description

Inactive Ingredient

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

Storage

Store at temperature
of 5 °C to 25 °C

Dosage and administration

Warning

Indicationg

Keep reach of Children

Keep away from Children

Purpose

Package

Package Label

INGREDIENTS AND APPEARANCE

OROXID SENSITIV 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81794-600
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 mL  in 1.5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81794-600-70	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2021
2	NDC: 81794-600-50	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2021
3	NDC: 81794-600-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2021
4	NDC: 81794-600-60	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/12/2021

OROXID SENSITIV 
hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81794-700
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 mL  in 1.5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81794-700-30	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/12/2021
2	NDC: 81794-700-40	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/12/2021

Labeler - Innova Medical Group (117663689)

Establishment
Name	Address	ID/FEI	Business Operations
Innova Medical Group		117663689	label(81794-600, 81794-700)

Establishment
Name	Address	ID/FEI	Business Operations
ENIKAM d.o.o.		520197715	manufacture(81794-600, 81794-700)