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

  • NDC Code(s): 49589-111-10, 49589-111-50
  • Packager: Izun Pharmaceutical Corporation
  • 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 November 8, 2024

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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
    • do not use if safety seal is broken, breached or missing
  • 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 1-877-210-2621 Monday thru Friday 8am-5pm EST

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Izun Healthcare Corp, New York,
    NY 10020 USA

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    PeriACTIVE®

    ADVANCED GUM CARE
    ORAL RINSE

    FRESHENS
    BREATH

    ALCOHOL
    FREE

    NATURAL
    BIOACTIVES

    MONEY BACK
    100%
    GUARANTEE

    CLINICALLY PROVEN
    to reduce inflammation

    REDUCES
    bacterial plaque

    REDUCES
    Gum Bleeding and Swelling

    HELPS PROTECT
    against Gingivitis

    PROMOTES
    healing and gum repair

    FRESH
    MINT

    HOMEOPATHIC
    SAFETY-SEALED
    FOR YOUR PROTECTION

    500 mL / 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:49589-111
    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 whole (UNII: QI7G114Y98) (Echinacea purpurea whole - UNII:QI7G114Y98) Echinacea purpurea whole4 [hp_X]  in 1 mL
    Centella asiatica whole (UNII: 7M867G6T1U) (Centella asiatica whole - UNII:7M867G6T1U) Centella asiatica whole4 [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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49589-111-5012 in 1 CARTON01/11/2009
    1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49589-111-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201902/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/11/2009
    Labeler - Izun Pharmaceutical Corporation (624194523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Abaco Partners LLC DBA Surefil964809417MANUFACTURE(49589-111) , LABEL(49589-111)
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