Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

  • 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 May 22, 2023

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  • Active Ingredients

    Sodium fluoride 0.02% w/v (0.01% fluoride ion)

    Purpose

    Antcavity

  • 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 and then spit it 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 - 25⁰ C (68⁰ - 77⁰ 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

  • Questions?

    Call 1-844-344-5071

  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Listerine 

  • Adverse Reactions

    DISTRIBUTED BY

    Lidl US, LLC

    Arlington, VA 22202

    1-844-344-5071

    www.Lidl.com

    Lidl Love it! Guarantee

    • money refunded
    • item replaced

    save water.lidl

    how2recycle.info

    Discard Seal, Empty & Replace Cap

    Plastic Bottle

  • Principal display panel

    ANTICAVITY MOUTHWASH

    SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

    ANTICAVITY FLUORIDE

    by LIDL

    COMPARE TO LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

    Kills Bad Breath and Strengthens Teeth to Help Prevent Cavities

    • Helps restore enemal
    • Helps prevent cavities

    IMPORTANT: read directions for proper use

    33.8 FL OZ (1.06 QT) 1L

    image description

  • principal display panel

    dentalux

    by LIDL MUTLI-CARE

    SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

    ANTIICAVITY FLUORIDE MOUTHWASH

    Compare to Listerine Total Care Anticavity Mouthwash*

    • Kills bad breath
    • Strengthen teeth
    • Helps resotre enamel
    • Helps prevent cavities

    Sealed with printed neckband for your protection

    Helps prevent cavities, restores enamel, & kills bad breath germs

    NDC-71141-159-32

    33.8 FL OZ (1.06 QT) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-159
    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:71141-159-321000 mL in 1 PACKAGE; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/09/2017
    Labeler - Lidl US, LLC (079389709)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(71141-159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(71141-159)
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