Label: SCOTTS SELECT PERIO RINSE STANNOUS FLUORIDE- stannous fluoride mouthwash

  • NDC Code(s): 69638-069-10
  • Packager: Scott's Dental Supply LLC
  • 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 August 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Stannous Fluoride 0.63%

  • Purpose

    Anticavity/Antigingivitis

  • Use

    Aids in the prevention of dental decay

    • helps prevent gingivitis
    • helps interfere with harmful effects of plaque associated with gingivitis.
  • Warnings

    Keep out of reach of children under 6 years of age. If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away. Do not swallow.

  • Directions

    • Do not use before mixing with water.

    Adults and children 6 year of age and older:

    • Use once a day after brushing your teeth with a toothpaste.
    • Remove cap and replace with pump.
    • Rotate spout counter clockwise to extend.
    • Depress pump until rinse comes to the tip of the pump.
    • Pump 1/8 fl. oz. into a cup. Add water to line (1 fl. oz.) on cup. Mix using bristle end of toothbrush.
    • Vigorously swish rinse between your teeth. for 1 min. and then spit out.
    • Do not swallow the rinse.
    • Do not eat or drink for 30 min. after rinsing.
    • Instruct children under 12 in good rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision.

    Children under 6: Consult a dentist or doctor.

  • Other Information

    • Store at room temperature 59-86°F (15-30°C)
    • This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • Inactive Ingredients

    Edetic Acid, Flavor, Glycerin, Saccharin Sodium, Xylitol.

  • PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label

    NDC 69638-069-10

    Scott's
    ✔SELECT
    PERIO RINSE

    0.63% Stannous
    Fluoride
    Concentrate
    With Xylitol

    MINT

    10 fl. oz. (296mL)

    REORDER 245-2030

    GLUTEN FREE
    SCOTT'S SELECT

    SCOTT'S SELECT
    HOME CARE

    Alcohol Free
    Dye Free
    Paraben Free

    SATISFACTION
    Quality
    GUARANTEED

    Important: Read directions
    thoroughly before use

    PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SCOTTS SELECT PERIO RINSE STANNOUS FLUORIDE 
    stannous fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-069
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.63 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-069-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product08/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/02/2015
    Labeler - Scott's Dental Supply LLC (137217043)
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