Label: ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 53942-163-86
  • Packager: Demoulas Super Markets, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 20, 2022

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  • Active Ingredient

    Sodium fluoride 0.02% w/v (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 12 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 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 controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
    • 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

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC

    875 EAST STREET

    TEWKSBURY, MA 01876

    DSP-TN-15000 DSP-MO-34 SDS-TN-15012

  • principal panel display

    "More for your dollar"

    MARKET BASKET

    Sealed With Printed Neckband For Your Protection

    MARKET BASKET

    Compare to Listerine Total Care Anticavity Mouthwash*

    ANTICAVITY MOUTHWASH

    Sodium Fluoride and Acidulated Phosphate Topical Solution

    Eucalyptus Mint

    • Helps prevent cavities
    • Helps strengthen teeth
    • Helps kill germs that cause bad breath
    • Freshens breath
    • Restores enamel

    IMPORTANT: Read directions for proper use.

    Sealed With Printed Neckband For Your Protection

    1L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-163
    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)  
    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:53942-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/13/2006
    Labeler - Demoulas Super Markets, Inc. (007869647)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(53942-163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(53942-163)
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