OROXID FORTE ORAL HYGIENE- hydrogen peroxide spray OROXID FORTE ORAL HYGIENE- hydrogen peroxide solution

OROXID Forte Oral Hygiene by

Drug Labeling and Warnings

OROXID Forte Oral Hygiene 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]

Keep out of reach of children

Keep away from children

Storage and Handling

Store at Temperature of 5ºc to 25ºc

Protect from Direct sunlight

Warning

Avoid direct contact with eyes

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

Use 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

Purpose

Active Ingredient

Hydrogen peroxide

Inactive ingredient

deionized water

Indication and usage

Product Description

Active Ingredient

Package Label

Main panel

Package label princile Display

INGREDIENTS AND APPEARANCE

OROXID FORTE ORAL HYGIENE 
hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81794-800
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.94 mL  in 2.94 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81794-800-30	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/21/2021
2	NDC: 81794-800-40	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/21/2021

OROXID FORTE ORAL HYGIENE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81794-900
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.94 mL  in 2.94 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81794-900-70	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2021
2	NDC: 81794-900-60	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2021
3	NDC: 81794-900-50	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2021
4	NDC: 81794-900-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/21/2021

Labeler - Innova Medical Group (117663689)

Establishment
Name	Address	ID/FEI	Business Operations
Innova Medical Group		117663689	label(81794-800, 81794-900)

Establishment
Name	Address	ID/FEI	Business Operations
ENIKAM d.o.o.		520197715	manufacture(81794-800, 81794-900)