Ionite APF

Manufacturer: Dharma Research, inc.
Effective date: 2020-11-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:33:57

Label at a glance#

ProductIonite APF

Active ingredientSODIUM FLUORIDE

Label structure5 sections

Storage and handling

Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products

Label contents#

Full prescribing information#

STORAGE AND HANDLING SECTION

Store at 59^o - 86^oF (15^o - 30^oC)
Protect from freezing
Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products

INACTIVE INGREDIENT SECTION

Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol

WARNINGS AND PRECAUTIONS SECTION

Keep out of the reach of children.
Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
Do not use on patients with an allergy Fluoride.
Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist.
For professional use only.

INSTRUCTIONS FOR USE SECTION

Shake well before use.
This is a four minute or one minute Fluoride gel for in-office patient use.
For best results, use at least twice a year.
After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness)
Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20200514_206_08_RevB20200514_206_17_RevB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1535362	sodium fluoride 2.72 % Oral Gel	PSN	3
1535362	sodium fluoride 0.0272 MG/MG Oral Gel	SCD	3
1535362	sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral Gel	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53045-206-08	2020-11-10	C162847	48780-1	9d75b9d0-6760-f424-e053-dadaa90a57ce	bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
53045-206-17	2020-11-10	C162847	48780-1	9d75b9d0-6760-f424-e053-dadaa90a57ce	bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
53045-206-08	2020-01-31	C162847	48780-1	9d75b9d0-6760-f424-e053-dadaa90a57ce	bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
53045-206-17	2020-01-31	C162847	48780-1	9d75b9d0-6760-f424-e053-dadaa90a57ce	bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53045-206-08	Ionite APF	245 g in 1 BOTTLE	GEL	245		3
53045-206-17	Ionite APF	490 g in 1 BOTTLE	GEL	490		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53045-206	IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20201117_bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4.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
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
HYDROFLUORIC ACID	INACTIVE INGREDIENT	RGL5YE86CZ	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Ionite APF
Sodium Fluoride
FLUORIDE ION
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE, DL-
XANTHAN GUM
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53045-206	53045-206-17, 53045-206-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
XANTHAN GUM	TTV12P4NEE	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 7 · 405 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 69 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii+dosage form 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route 69 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii+dosage form 18 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET / ORAL	60 mg		Exact identifier — unii+route 36 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+dosage form 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii+dosage form 63 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii+route 63 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii+route 30 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 63 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii+route 63 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii+route 78 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii+route 69 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 69 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 69 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii+route 69 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii+route 69 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii+route 63 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii+route 78 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii+dosage form 69 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii+route 78 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route 78 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii+route 63 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 69 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii+route 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii+route 78 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET / ORAL	60 mg		Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 69 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 69 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii+dosage form 78 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 63 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii+route 63 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET / ORAL	60 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii+route 69 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route 78 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii+route 63 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	GRANULE, FOR SUSPENSION / ORAL	12.5 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii+route 69 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii+route 30 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET, CHEWABLE / ORAL	12 mg		Exact identifier — unii+route 36 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SYRUP / ORAL	100 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	PASTE, DENTIFRICE / DENTAL	ADJ PH		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii+route 69 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 78 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 78 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	SODIUM FLUORIDE	Dharma Research, inc.	bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4	2020-11-16	Warnings	Exact identifier ndc (package): 53045-206-08 ndc (package): 53045-206-17 ndc (product): 53045-206 ndc11 (package): 53045020617 ndc11 (package): 53045020608 spl id: 373417c2-b73d-4928-978a-ffa2b4b38746 spl set id: bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4

Reported adverse events (FAERS/openFDA)#

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