Label: ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 41163-581-86
  • Packager: United Natural Foods, Inc. dba UNFI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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  • Active ingredient

    Sodium fluoride 0.02% (0.009% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    for this product

  • 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 (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

  • Tamper Evident Statement

    Sealed With Printed Neckband For Your Protection

  • Disclaimer

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

  • Adverse reaction

    Like it or let us make it right.

    That is our quality promise.

    855-423-2630

    DISTRIBUTED BY UNFI

    PROVIDENCE, RI 02908 USA

  • Principal panel display

    compare to Act Restoring® Anticavity Fluoride Mouthwash Cool Mint active ingredient*

    EQUALINE®

    restoring

    anticavity

    fluoride

    mouthwash

    • restores enamel
    • helps avoid tooth decay

    refreshing mint

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    33.8 FL OZ (1.05 QT) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-581
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-581-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02110/26/2020
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41163-581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41163-581)
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