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Ionite H by Dharma Research, Inc.

Medically reviewed on August 3, 2017

Dosage form: mouthwash
Ingredients: STANNOUS FLUORIDE 0.63mg in 100mL
Labeler: Dharma Research, Inc.
NDC Code: 53045-276

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, 0.63%

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

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)

IONITE H 
stannous fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-276
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.63 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETIC ACID 
GLYCERIN 
SACCHARIN SODIUM 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53045-276-10269 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/03/2015
Labeler - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIOperations
Dharma Resarch, Inc.078444642manufacture(53045-276)

 
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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