Label: PCXX NAF RNS MINT- sodium fluoirde rinse

  • 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 November 22, 2017

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  • DOSAGE & ADMINISTRATION

    Adults and children 6 years of age and older:

    use once a day after brushing your teeth with a toothpaste
    remove cap
    hold bottle upright and squeeze. Fill to FILL LINE
    pour out. Only the correct 10 milliliters dose will pour out
    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 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.

  • WARNINGS

    Keep out of reach of children.

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

  • INACTIVE INGREDIENT

    potassium sorbate, xylitol, sucralose, water

  • INDICATIONS & USAGE

    Aids in the prevention of dental cavities

  • ACTIVE INGREDIENT

    Sodium Fluoride 0.05%

  • KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

    Anticavity

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    PCXX NAF RNS MINT 
    sodium fluoirde rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62007-400
    Route of AdministrationTOPICAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.04 mg  in 1 mL
    XYLITOL (UNII: VCQ006KQ1E) 0.5 mg  in 1 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 0.01 mg  in 1 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-400-161 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/22/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/22/2017
    Labeler - Ross Healthcare Inc. (244249012)
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