Label: IONITE H- stannous fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 2, 2015

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  • Active Ingredient

    Stannous fluoride, 0.4%

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities (caries).

  • Warnings

    Keep out of reach of children.  If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Do not swallow.

    Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.

  • Directions

    • This is not a toothpaste. Read directions carefully before using.
    • Adults and children 6 years of age and older:
      o Use once per day after brushing teeth thoroughly with toothpaste
      o Twist off cap to remove foil seal
      o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces.
      o Allow the gel to remain on your teeth for 1 minute
      o Spit out. Do not swallow
      o Do not eat, drink, or rinse for at least 30 minutes
    • Children under 6: consult a dentist or doctors

  • 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

    Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, 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

  • Ionite H

    NDC 53045-271-04

    Home Care

    0.4% Stannous Fluoride Gel with Xylitol

    Anticavity Fluoride Preventative Treatment Gel

    Bubble Gum

    Made in USA

    Gluten Free Dye Free

    Reorder#: 56-00131

    4.3 oz. (122 g)

    20150802 271 SnF2 BubGm revB

  • INGREDIENTS AND APPEARANCE
    IONITE H 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-271
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.4 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-271-04122 g in 1 TUBE; 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 - Dharma Research, Inc. (078444642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Research, Inc.078444642manufacture(53045-271)