Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

  • NDC Code(s): 41163-213-44
  • Packager: United Natural Foods, Inc. dba UNFI
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 11, 2023

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  • 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.

  • Directions 

    • 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 inside of cap); do not fill above 10 ML mark
    • vigorously swish 10 milliliters 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
  • Other information

    • store at room temperature
  • Inactve 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

  • SPL UNCLASSIFIED SECTION

    Sealed with printed Neckband for your protection

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

    Like it or Let us make it right.

    That's our quality promise.

    855-423-2630

    DISTRIBUTED BY UNFI

    PROVIDENCE, RI 02908 USA

  • Principal Panel Display

    NDC 41163-213-44

    comapre to Act Anticavity Fluoride Rinse active ingredient*

    EQUALINE

    anticavity

    fluoride

    rinse

    • does not contain ethyl alcohol
    • helps prevent cavities
    • helps strengthen tetth
    • freshens breath

    mint

    INPORTANT: READ DIRECTIONS FOR PROPER USE.

    18FL OZ (532mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE.5 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:41163-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/14/2009
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41163-213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(41163-213)
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