Label: IONITE H- stannous fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 11, 2023

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  • Active Ingredient

    Stannous Fluoride, 0.63%

  • Purpose

    Anticavity/Antigingivitis

  • Uses

    • 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 years of age and older:
       - Use once per day after brushing your teeth with 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 the 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

  • SPL UNCLASSIFIED SECTION

    Manufactured by Dharma Research, Inc.

    www.dharmaresearch.com

    5220 N.W. 72 Avenue, Unit 15

    Miami, FL 33166

    1-877-833-3725

    Reorder#: 56-00136

  • Ionite H

    NDC 53045-276-10

    PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE

    0.63 Stannous Fluoride Concentrate with Xylitol

    Alcohol Free

    Fruit Punch

    IMPORTANT: Read directions for proper use.

    Made in USA

    Dye Free Gluten Free Paraben Free

    Home Care

    10 fl. oz. (296 mL)

    20150803 276 SnF2 Frt Pnch rev B

  • INGREDIENTS AND APPEARANCE
    IONITE H 
    stannous fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-276
    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
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-276-10269 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/03/2015
    Labeler - Dharma Research, Inc. (078444642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Resarch, Inc.078444642manufacture(53045-276)
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