Label: PERIACTIVE- sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated February 6, 2019

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • ACTIVE INGREDIENT

    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

    • 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.

    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
    • 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

    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

    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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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