IZUN PERIACTIVE MOUTHWASH- sambucus nigra flower extract, centella asiatica leaf extract, echinacea purpurea extract mouthwash

IZUN Periactive Mouthwash by

Drug Labeling and Warnings

IZUN Periactive Mouthwash by is a Otc medication manufactured, distributed, or labeled by Izun Pharmaceuticals Corporation, Incos Cosmeceutica Industriale Srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Sambucus nigra flower extract, 3x

Centella Asiatica Leaf Extract, 4x

Echinacea Purpurea Extract, 4x

INACTIVE INGREDIENT

Inactive Ingredients:

Aqua, Propylene Glycol, Sorbitol, PEG-40 Hydrogenated Castor Oil, Cetylpyridinum Chloride, Lactic Acid, Sodium Benzoate, Disodium EDTA, Maltodextrin, Sucralose, CI 42090, Aroma

PURPOSE

Irritation / gingivitus reducer / gum repair reducer

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age. In case more than is used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years and older	rinse for 60 seconds with 15 ml (3 teaspoonful twice a day)
children 6-12 years	rinse for 60 seconds with 10 ml (2 teaspoonful twice a day)
children under 6 years of age	do not use

• do not eat, drink or rinse your mouth for 30 minutes after use
• do not swallow
• children 6 years to under 12 years of age: supervise use

INDICATIONS & USAGE

Uses

Helps protect against gingivitis
Helps reduce gum bleeding and soreness
Helps reduce plaque formation
Helps reduce gum inflammation
Promotes gingival healing

WARNINGS

Allergy Alert

Do not use if allergic to any of the ingredients. Stop use and ask a dentist if:

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be the signs of periodontitis, a serious form of gum disease

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IZUN PERIACTIVE MOUTHWASH 
sambucus nigra flower extract, centella asiatica leaf extract, echinacea purpurea extract mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49589-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENTELLA ASIATICA LEAF (UNII: 6810070TYD) (CENTELLA ASIATICA LEAF - UNII:6810070TYD)	CENTELLA ASIATICA LEAF	4 [hp_X]  in 1 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	4 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T)	SAMBUCUS NIGRA FLOWER	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
LACTIC ACID (UNII: 33X04XA5AT)
BRILLIANT BLUE G (UNII: M1ZRX790SI)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49589-112-01	500 mL in 1 TUBE; Type 0: Not a Combination Product	08/24/2018
2	NDC: 49589-112-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	08/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2018

Labeler - Izun Pharmaceuticals Corporation (624194523)

Establishment
Name	Address	ID/FEI	Business Operations
Incos Cosmeceutica Industriale Srl		434933032	manufacture(49589-112)