MULTI-ACTION ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [AMAZON]

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MULTI-ACTION ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [AMAZON]
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NDC 72288-299-86
Set ID 91626efe-520d-457f-8d72-7a95a8877301
Category HUMAN OTC DRUG LABEL
Packager Amazon.com Services LLC
Generic Name
Product Class
Product Number
Application Number PART356
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  • claims

    "Alexa, reorder Amazon Basics Antiseptic Rinse"

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

    This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurence

    active ingredients

    Cetylpyridinium Chloride 0.07%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    for this product

    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 gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 years to under 12 years of age: supervise use
    • when used after brushng, rinse mouth with water first
    • children under 6 years of age: do not use
  • Other information

    • this rinse is not intended to replace brushing or flossing
  • inactive ingredients

    water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

  • Adverse reactions

    DISTRIBUTED BY:

    Amazon.com Services LLC

    Seattle, WA 98109

    1-877-485-0385

    2021 Amazon.com, Inc or its Affiliates.  All rights reserved. 

    www.amazon.com/amazonbasics

  • principal display panel

    amazon basics

    multi action

    antiseptic

    rinse

    Antigingivitis/Antiplaque Mouthwash

    Alcohol Free

    Fresh Mint

    33.8 FL OZ (1L)

    image description

  • INGREDIENTS AND APPEARANCE
    MULTI-ACTION ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-299
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/25/2018
    Labeler - Amazon.com Services LLC (128990418)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72288-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72288-299)
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