Label: X-PUR OPTI-RINSE PLUS- anticavity fluoride rinse mouthwash

  • 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 October 29, 2022

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  • Active Ingredient(s)

    Sodium Fluoride 0.05% (0.02% w/v fluoride ion)............Anticavity

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities.

  • Warnings

    Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

    Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

  • STOP USE

    Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

  • KEEP OUT OF REACH OF CHILDREN

    If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Adults and children 6 years and older:

    Use once a day after brushing your teeth with a toothpaste
    Remove cap
    Pour 10 milliliters into a cap (10 mL mark on the 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 brushing and rinsing habits (to minimize swallowing)
    Supervise children as necessary until capable of using without supervision

    • Children 6 years and under

    Consult a dentist or doctor

  • Inactive ingredients

    xylitol, glycerin, poloxamer 407, sodium phosphate, bioflavonoids, benzoic acid, cetylpyridinium chloride, mint flavor, blue 1, water,

  • OTHER SAFETY INFORMATION

    store at room temperature (59-86°F) do not use if safety seal is broken or missing

  • Package Label - Principal Display Panel

    500 mL NDC: 81359-114-11500 mL NDC: 77982-114-11

  • INGREDIENTS AND APPEARANCE
    X-PUR OPTI-RINSE PLUS 
    anticavity fluoride rinse mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77982-114
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    MINT (UNII: FV98Z8GITP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77982-114-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/18/2021
    Labeler - Laboratoires MSP Inc (251046124)
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