Label: ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 72288-439-43, 72288-439-45
  • Packager: Amazon.com Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • Active Ingredient

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • WARNINGS

    Warnings

  • Keep out of reach of children.

    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 of age and older:

    • use twice a day after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • Inactive ingredients

    water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

  • Other information

    store at room temperature (59º-77ºF)

  • SPL UNCLASSIFIED SECTION

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION 

    DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

    DISTRIBUTED BY:

    Amazon.com, Services, LLC

    Seattle, WA 98109

    1-877-485-0385

    2021Amazon.com, Inc. or its afiliated.

    All rights reserved.

    www.amazon.com/amazonbasics

  • principal display panel

    amazon basics

    whitening

    anticavity

    mouthwash

    Removes Surface Stains From Teeth

    Fresh Mint Flavor

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    16 FL OZ (473mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-439
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-439-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2018
    2NDC:72288-439-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/01/2018
    Labeler - Amazon.com Services LLC (128990418)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(72288-439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091520manufacture(72288-439)
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