Label: ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 41163-043-86
  • Packager: United Natural Foods, Inc. dba UNFI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Active ingredent

    Sodium fluoride 0.02% (0.01% 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 daily after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) 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
    • 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 controlled room temperature 20°-25° C to (68°-77°F)
    • cold weather may temporarily cloud this product
  • Inactive ingredients

    water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

  • Tamper Evident Statement

    Sealed With Printed Neckband For Your Protection

    Do Not Use If Band Around Cap Is Broken Or Missing.

  • Disclaimer

    *This product is not manufactured or distributed by Kenvue, Inc, distributor of Listerine® Total Care Anticavity Mouthwash.

  • Adverse Reaction

    Like it or let us make it right.

    That's our quality promise.

    855-423-2360

    DISTRIBUTED BY UNFI PROVIDENCE< RI 02908 USA

    DSP-TN-21091

    DSP-MO-20087

  • Principal display panel

    compare to Listerine® Total Care Anticavity Mouthwash active ingredient*

    EQUALINE®

    multiple benefit

    anticavity mouthwash

    sodium fluoride and acidulated phosphate topical solution

    • helps strengthen teeth to help prevent cavities
    • helps restore enamel
    • kills germs that cause bad breath

    IMPORTANT: read directions for proper use.

    mint eucalyptus

    33.8 FL OZ (1.05QT) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    THYMOL (UNII: 3J50XA376E)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-043-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02109/13/2009
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(41163-043)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(41163-043)
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