Ionite APF

Manufacturer: Dharma Research, Inc.
Effective date: 2020-10-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:33:44

Label at a glance#

ProductIonite APF Foam

Active ingredientSODIUM FLUORIDE

Label structure5 sections

Storage and handling

Store at a controlled room temperature 59 o -86 o F (15 o -30 o C)

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

WARNINGS AND PRECAUTIONS SECTION

Do not swallow.
Keep out of reach of children.
Contents under pressure.
Do not place in hot water or near radiators, stoves or other sources of heat.
Do not puncture or incinerate container. Do not spray towards open flames.
For professional use only.

INSTRUCTIONS FOR USE SECTION

Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
To dispense,invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
Air dry teeth thoroughly and inset tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
Use a saliva ejector during treatment to minimize ingestion of product.
Remove the tray(s) and have patient expectorate.
Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

STORAGE AND HANDLING SECTION

Store at a controlled room temperature 59^o-86^oF (15^o-30^oC)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RevB.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
831719	sodium fluoride 1.23 % Oral Foam	PSN	3
831719	sodium fluoride 12.3 MG/ML Oral Foam	SCD	3
831719	sodium fluoride 1.23 % Oral Foam	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53045-250-44	2020-10-27	C162847	48780-1	9d75b9d0-c3fa-f424-e053-dadaa90a57ce	8987b447-3fa3-4f52-aecc-80e44c981aaa
53045-250-44	2020-01-31	C162847	48780-1	9d75b9d0-c3fa-f424-e053-dadaa90a57ce	8987b447-3fa3-4f52-aecc-80e44c981aaa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53045-250-44	Ionite APFFoam	126 g in 1 BOTTLE	AEROSOL, FOAM	126		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53045-250	IONITE APF FOAM (SODIUM FLUORIDE) AEROSOL, FOAM [DHARMA RESEARCH, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20201028_8987b447-3fa3-4f52-aecc-80e44c981aaa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	1
HYDROFLUORIC ACID	INACTIVE INGREDIENT	RGL5YE86CZ	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Ionite APF Foam
Sodium Fluoride
FLUORIDE ION
CASTOR OIL
DECYL GLUCOSIDE
WATER
HYDROFLUORIC ACID
PHOSPHORIC ACID
SODIUM BENZOATE
SODIUM LAURETH SULFATE
SACCHARIN SODIUM
XYLITOL
POLOXAMER 407
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53045-250	53045-250-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
CASTOR OIL	D5340Y2I9G	IACT
DECYL GLUCOSIDE	Z17H97EA6Y	IACT
WATER	059QF0KO0R	IACT
HYDROFLUORIC ACID	RGL5YE86CZ	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
XYLITOL	VCQ006KQ1E	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
TROLAMINE	9O3K93S3TK	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 4 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii+route 32 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii+route 46 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii+route 20 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 20 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	LOTION, AUGMENTED / TOPICAL		1 mg	Exact identifier — unii+route 32 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	TABLET / ORAL	0.91 mg		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 54 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	CREAM / TOPICAL		13 mg	Exact identifier — unii+route 32 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / TOPICAL		28 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii+route 46 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii+route 54 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii+dosage form 32 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii+route 20 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii+dosage form 32 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SPRAY / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii+route 20 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 32 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii+route 54 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii+route 54 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii+dosage form 32 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	PASTE, DENTIFRICE / DENTAL	ADJ PH		Exact identifier — unii+route 32 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii+route 32 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii+route 32 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii+route 54 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 54 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 APF Foam	SODIUM FLUORIDE	Dharma Research, Inc.	8987b447-3fa3-4f52-aecc-80e44c981aaa	2020-10-27	Warnings	Exact identifier ndc (package): 53045-250-44 ndc (product): 53045-250 ndc11 (package): 53045025044 spl id: 86b603bc-a794-4814-9216-366a80d7642b spl set id: 8987b447-3fa3-4f52-aecc-80e44c981aaa

Reported adverse events (FAERS/openFDA)#

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