FDA.reportPublic FDA data

IZUN Periactive Mouthwash

Manufacturer
Izun Pharmaceuticals Corporation | Incos Cosmeceutica Industriale Srl
Effective date
2019-01-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:32:10

Label at a glance#

ProductIZUN Periactive Mouthwash
Active ingredientCENTELLA ASIATICA LEAF, ECHINACEA PURPUREA, SAMBUCUS NIGRA FLOWER
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sambucus nigra flower extract, 3x

Centella Asiatica Leaf Extract, 4x

Echinacea Purpurea Extract, 4x

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

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

OTC - PURPOSE SECTION

Irritation / gingivitus reducer / gum repair reducer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Directions

Adults and children 12 years and olderrinse 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 SECTION

Uses

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

WARNINGS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELlabellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-137290015115001GTIN-13: 7290015115001
EAN-13: 7290015115001
GTIN storage (14 digits): 07290015115001		Pages from PeriActive FDA registration (includes label)_Page_2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49589-112-012024-11-12C16284748780-1ba0f9c33-4ded-a910-e053-dadaa90a0b85Izun Periactive Mouthwash
49589-112-022024-11-12C16284748780-1ba0f9c33-4ded-a910-e053-dadaa90a0b85Izun Periactive Mouthwash
49589-112-012021-01-29C16284748780-1ba0f9c33-4ded-a910-e053-dadaa90a0b85Izun Periactive Mouthwash
49589-112-022021-01-29C16284748780-1ba0f9c33-4ded-a910-e053-dadaa90a0b85Izun Periactive Mouthwash

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49589-11249589-112-01, 49589-112-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENTELLA ASIATICA LEAF6810070TYDACTIB
SODIUM BENZOATEOJ245FE5EUIACT
ECHINACEA PURPUREAQI7G114Y98ACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
LACTIC ACID33X04XA5ATIACT
BRILLIANT BLUE GM1ZRX790SIIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cc57a49b-d845-4529-9184-b7dddd42527a7430cde1-3302-080a-e053-2991aa0adc842024-11-13WarningsExact identifier
spl set id: 7430cde1-3302-080a-e053-2991aa0adc84

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.