IONITE H- stannous fluoride gel, dentifrice

Ionite H by

Drug Labeling and Warnings

Ionite H by is a Otc medication manufactured, distributed, or labeled by Dharma Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

IONITE H 
stannous fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53045-271
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.4 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-271-04	122 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/02/2015

Labeler - Dharma Research, Inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(53045-271)