PERIACTIVE- sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash 
Izun Pharmaceuticals Corp

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

PeriActive®

Drug Facts:

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

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.

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

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

Other information

This rinse is not intended to replace brushing or flossing

Inactive ingredients

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?

Call 1-800-956-2595

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

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
PERIACTIVE 
sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49589-199
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sambucus nigra flower (UNII: 07V4DX094T) (Sambucus nigra flower - UNII:07V4DX094T) Sambucus nigra flower3 [hp_X]  in 1 mL
Echinacea purpurea (UNII: QI7G114Y98) (Echinacea purpurea - UNII:QI7G114Y98) Echinacea purpurea4 [hp_X]  in 1 mL
Centella asiatica (UNII: 7M867G6T1U) (Centella asiatica - UNII:7M867G6T1U) Centella asiatica4 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
cetylpyridinium chloride (UNII: D9OM4SK49P)  
edetate disodium (UNII: 7FLD91C86K)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
maltodextrin (UNII: 7CVR7L4A2D)  
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
propylene glycol (UNII: 6DC9Q167V3)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49589-199-5012 in 1 CARTON02/01/2019
1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49589-199-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC02/01/2019
Labeler - Izun Pharmaceuticals Corp (624194523)

Revised: 2/2019
Document Id: b4855c55-bd4e-4ac8-bc23-c9d6bd8f03da
Set id: e5cf9d77-43bf-4856-9f91-b9cd7a648746
Version: 3
Effective Time: 20190206
 
Izun Pharmaceuticals Corp