Sorbet APF

Manufacturer: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Effective date: 2022-01-24
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:12:40

Label at a glance#

ProductSorbet APF

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

Dosage and administration

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxis, fill two single or one dual tray(s), one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (1...

Storage and handling

Store at a controlled room temperature 59° to 86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredient:

SPL UNCLASSIFIED SECTION

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

SPL UNCLASSIFIED SECTION

Fluoride Treatment Gel.

Indications and Usage:

INDICATIONS & USAGE SECTION

A stable thixotropic fluoride treatment gel used to help prevent dental decay.

For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

Warnings:

WARNINGS SECTION

Keep out of 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.
Read directions carefully before using.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxis, fill two single or one dual tray(s), one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other information:

STORAGE AND HANDLING SECTION

Store at a controlled room temperature 59° to 86°F (15°-30°C). Protect from freezing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB.Sorbet APF Gel CE_vanilla.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	3
Magnesium Aluminum Silicate	INACTIVE INGREDIENT	6M3P64V0NC	3
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	3
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	3
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Sorbet APF
Sodium Fluoride
CITRIC ACID MONOHYDRATE
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
SODIUM BENZOATE
SACCHARIN SODIUM
WATER
XANTHAN GUM
XYLITOL
TITANIUM DIOXIDE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68400-705	68400-705-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
XYLITOL	VCQ006KQ1E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

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 6 · 311 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAVENOUS		1294 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 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
16384559-cf07-3e0c-e063-6394a90a1a5d			f6f4d681-d67c-4dec-b56d-b05f362fa57c	2024-04-16	Warnings	Exact identifier spl set id: f6f4d681-d67c-4dec-b56d-b05f362fa57c

Reported adverse events (FAERS/openFDA)#

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