Ionite H

Manufacturer: Dharma Research, Inc.
Effective date: 2023-10-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:56:41

Label at a glance#

ProductIonite H

Active ingredientSTANNOUS FLUORIDE

Label structure9 sections

Indications and uses

Aids in the prevention of dental decay Helps prevent gingivitis Helps interfere with harmful effects of plaque associated with gingivitis

Dosage and administration

Contacts and useful links#

PhoneLabel contact1-877-833-3725

Websitewww.dharmaresearch.com

www.dharmaresearch.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride, 0.63%

Purpose

OTC - PURPOSE SECTION

Anticavity/antigingivitis

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay

Helps prevent gingivitis

Helps interfere with harmful effects of plaque associated with gingivitis

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - DO NOT USE SECTION

Do not swallow.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

Edetic acid, Flavor, Glycerin, Saccharin Sodium, 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

Reorder#: 56-00135

Ionite H

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
583459	stannous fluoride 0.63 % Dental Solution	PSN	2
583459	stannous fluoride 6.3 MG/ML Mouthwash	SCD	2
583459	stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution	SY	2
583459	stannous fluoride 0.63 % Dental Solution	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53045-275-10	Ionite H	296 mL in 1 BOTTLE, DISPENSING	MOUTHWASH	296		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53045-275	IONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20231012_5c312b36-07f4-406e-b3d3-c6d1e964635d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Ionite H
Stannous Fluoride
FLUORIDE ION
EDETIC ACID
GLYCERIN
SACCHARIN SODIUM
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53045-275	53045-275-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STANNOUS FLUORIDE	3FTR44B32Q	ACTIM
EDETIC ACID	9G34HU7RV0	IACT
GLYCERIN	PDC6A3C0OX	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
XYLITOL	VCQ006KQ1E	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 68 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SOLUTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / TOPICAL	0.06 %w/v		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBMUCOSAL	0.03 %w/v		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii+dosage form 8 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / TOPICAL	0.06 %w/v		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBMUCOSAL	0.03 %w/v		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUPPOSITORY / RECTAL		7 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	TABLET / ORAL	4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii+route 8 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUPPOSITORY / RECTAL		7 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SOLUTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii+dosage form 8 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / INTRAVENOUS		2 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii+route 8 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 26 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier ndc (package): 53045-275-10 ndc (product): 53045-275 ndc11 (package): 53045027510 spl id: 48ad63b9-3911-40fe-8bd2-bcace77e5713 spl set id: 5c312b36-07f4-406e-b3d3-c6d1e964635d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.