IONITE H- stannous fluoride gel, dentifrice 
Dharma Research, Inc.

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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

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 53045-271-04

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

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 DrugM02108/02/2015
Labeler - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(53045-271)

Revised: 10/2023
Document Id: 91060eb1-2d2e-4100-912f-05e7b46c9ae3
Set id: 042636cf-8b61-4022-b0a1-af09c06b145b
Version: 2
Effective Time: 20231011
 
Dharma Research, Inc.