Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

  • NDC Code(s): 72288-213-44
  • Packager: Amazon.com Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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

  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

  • Active ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities

  • Warning

    for this product

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • Directiions

    • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
    • remove cap
    • pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
    • vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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
  • Other information

    • store at room temperature
  • Inactive ingredients

    water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

  • Adverse reactions

    *This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Flouride Mouthwash.

    "Alexa, reorder Amazon Bascs Fluoride Rinse."

    DISTRIBUTED BY:

    Amazon.com Services, LLC

    Seattle, WA 98109

    1-877-485-0385

    (c) 2021 Amazon.com, Inc. or its affiliates.

    All rights reserved. 

    www.amazon.com/amazonbasics

  • Principal display panel

    amazon basics

    anticavity

    fluoride

    rinse

    Alcohol Free

    Mint Flavor

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    Compare to Act Anticavity Fluoride Mouthwash*

    18 FL OZ (532 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-213
    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)  
    SORBITOL (UNII: 506T60A25R)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/24/2018
    Labeler - Amazon.com Services LLC (128990418)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(72288-213)