Label: OPTIRINSE PLUS- remineralizing fluoride rinse liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 6, 2020

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  • Active Ingredients (in 10 mL)

    Cetylpyridinum Chloride 0.05%

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

  • Purpose

    Antigingivitis/antiplaque

    Anticavity

  • Uses

    • Aids in the prevention of dental cavities
    • Helps prevent and reduce plaque and gingivitis
    • Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
  • 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.
  • WARNINGS

    • Ask a dentist if symptoms persist or condition worsens after regular use.
  • Directions

     Adults and children 6 years of age 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 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 12 years under 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 room temperature (15-30°C)
    • Do not use if safety seal is broken or missing
  • Inactive Ingredients

    Purified Water, Xylitol, Glycerin, Grape Flavor, Poloxamer 407, Bioflavonoids, Sodium Phosphate, Benzoic Acid, Mint Flavor, Red 40

  • OptiRinse Plus - Grape - 500 mL - NDC 77982-001-01

    optirinse-500ml

    OptiRinse Plus

    Contains Citrox patented formula

    Natural Bioflavinoid Complex

    Ideal for Adults & children

    00.05% NAF Remineralizing Fluoride Rinse

    Grape Flavor

    16.9 fl oz (500 ml)

    Recommended by Dental Professionals

    • Anti-cavities
    • Anti-gingivitis
    • 10% Xylitol
    • Alcohol free
    • Kills bacteria
    • Lightly flavored
    • Neutral pH

    Questions? 1 888 442.7070 or boutique.oralscience.com

    Distributed in USA by:

    TruLife Distribution, 401 E Las Olas Blvd Suite 1400, Fort Lauderdale,

    Floirida USA 33301 / 954.414.0380

    X-PUR is a registered trademark of Oral Science Inc.

  • INGREDIENTS AND APPEARANCE
    OPTIRINSE PLUS 
    remineralizing fluoride rinse liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77982-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 mg  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PULEGONE (UNII: 4LF2673R3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77982-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/04/2020
    Labeler - Laboratoires MSP Inc (251046124)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires MSP Inc251046124manufacture(77982-001)
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