Label: IONITE H- stannous fluoride mouthwash

  • 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 February 17, 2021

If you are a consumer or patient please visit this version.

  • 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.jpg

  • 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 finalpart35508/03/2015
    Labeler - Dharma Research, Inc. (078444642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Resarch, Inc.078444642manufacture(53045-276)