IONITE H- stannous fluoride mouthwash 
Dharma Research, Inc.

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Active Ingredient

Stannous fluoride, 0.63%

Purpose

Anticavity/antigingivitis

Uses

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

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#: 56-00135

Ionite H

NDC 53045-275-10

PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE

0.63 Stannous Fluoride Concentrate with Xylitol

Alcohol Free

Spearmint

IMPORTANT: Read directions for proper use.

Made in USA

Dye Free Gluten Free Paraben Free

Home Care

10 fl. oz. (296 mL)

20150803 275 SnF2 Spmt revB

IONITE H 
stannous fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-275
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
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-275-10296 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 Research, Inc.078444642manufacture(53045-275)

Revised: 10/2023
Document Id: 48ad63b9-3911-40fe-8bd2-bcace77e5713
Set id: 5c312b36-07f4-406e-b3d3-c6d1e964635d
Version: 2
Effective Time: 20231011
 
Dharma Research, Inc.