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Ionite H by Dharma Research, Inc.

Medically reviewed on August 2, 2017

Dosage form: gel, dentifrice
Ingredients: STANNOUS FLUORIDE 0.4mg in 100g
Labeler: Dharma Research, Inc.
NDC Code: 53045-270

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.

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 than 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 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

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

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 53045-270-04

Home Care

0.4% Stannous Fluoride Gel with Xylitol

Anticavity Fluoride Preventative Treatment Gel

Spearmint

Made in USA

Gluten Free Dye Free

Reorder#: 56-00130

4.3 oz. (122 g)

IONITE H 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-270
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.4 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
SODIUM HYDROXIDE 
WATER 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53045-270-04122 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/02/2015
Labeler - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIOperations
Dharma Research, Inc.078444642manufacture(53045-270)

 
Dharma Research, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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