Label: SODIUM FLUORIDE solution

  • 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 July 1, 2015

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  • Active Ingredient

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

    Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

  • 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 (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

  • Other information

    store at room temperature (59º-77ºF)

  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Anticavity Mouthrinse

  • Principal Display Panel

    SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    IMPORTANT: read directions for proper use

    Whitening

    Anticavity mouth rinse

    Begins working on contact

    5 days to whiter teeth

    Helps strengthen teeth

    Kills germs that cause bad breath

    Fresh mint flavor

    32 fl oz (946 mL)

    mm01

  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    sodium fluoride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-435
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/28/2015
    Labeler - Target Corp. (006961700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc.790752542manufacture(11673-435) , analysis(11673-435)
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