PeriActive

Manufacturer
Izun Pharmaceuticals Corp
Effective date
2019-02-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:31:19

Label at a glance#

ProductPeriActive
Active ingredientSambucus nigra flower, Echinacea purpurea, Centella asiatica
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and older rinse for 60 seconds with 15ml (3 teaspoonful) twice a day children 6-12 years rinse for 60 seconds with 10ml (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

Storage and handling

This rinse is not intended to replace brushing or flossing store at room temperature 15-30°C (59-86°F) keep out of direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 15ml)Purposes
  • Sambucus nigra 3x
Irritation/gingivitis reducer
gum repair stimulator
  • Echinacea purpurea 4x
Irritation/gingivitis reducer
  • Hydrocotyle asiatica 4x
Irritation/gingivitis reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and olderrinse for 60 seconds with 15ml (3 teaspoonful) twice a day
children 6-12 yearsrinse for 60 seconds with 10ml (2 teaspoonful) twice a day
children under 6 years of agedo 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

Other information

STORAGE AND HANDLING SECTION

This rinse is not intended to replace brushing or flossing

  • store at room temperature 15-30°C (59-86°F)
  • keep out of direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetylpyridinium chloride, cool mint flavor1, disodium EDTA, FD&C Blue No. 1 ,lactic acid, maltodextrin, menthol, nat. cinnamon flavor1, PEG-40 hydrogenated castor oil, propylene glycol, sodium benzoate, sorbitol, sucralose, water, wintergreen flavor1

1 contains one or more of these ingredients

Questions?

OTC - QUESTIONS SECTION

Call 1-800-956-2595

SPL UNCLASSIFIED SECTION

Distributed By: straumann
Institut Straumann AG
Peter Merian-Weg 12 | 4002 Basel | Switzerland

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PeriACTIVE®

DISTRIBUTED BY STRAUMANN

ADVANCED GUM CARE

ORAL RINSE

Powered by Nature

CLINICALLY PROVEN
to Reduce Inflammation

KILLS BACTERIA

REDUCES
Gum Bleeding & Soreness

PROTECTS
Against Plaque & Gingivitis

Fresh Mint

HOMEOPATHIC

500 mL e (16.9 fl. oz.)

Principal Display Panel - 500 mL Bottle Label
Principal Display Panel - 500 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49589-199-102024-11-12C16284748780-1ba0f9c33-1030-a910-e053-dadaa90a0b85PeriActive ®
49589-199-502024-11-12C16284748780-1ba0f9c33-1030-a910-e053-dadaa90a0b85PeriActive ®
49589-199-102021-01-29C16284748780-1ba0f9c33-1030-a910-e053-dadaa90a0b85PeriActive ®
49589-199-502021-01-29C16284748780-1ba0f9c33-1030-a910-e053-dadaa90a0b85PeriActive ®

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
49589-19949589-199-50, 49589-199-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
7e007051-9a0a-4d9b-8c98-ca052c987162e5cf9d77-43bf-4856-9f91-b9cd7a6487462024-11-08WarningsExact identifier
spl set id: e5cf9d77-43bf-4856-9f91-b9cd7a648746

Reported adverse events (FAERS/openFDA)#

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