Topical 60 Sec Sodium Fluoride

Manufacturer: Patterson Dental Supply Inc
Effective date: 2018-12-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:27:25

Label at a glance#

ProductTopical 60 Sec Sodium Fluoride Bubble Gum

Active ingredientSodium Fluoride

Label structure10 sections

Indications and uses

For topical application to aid in the prevention of dental caries. Treatment frequency should not exceed 4 treatments per year.

Dosage and administration

Shake can thoroughly for at least 10 seconds before each use. Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Dry tooth surface and insert tray(s) into mouth. Have patient bite down for 1 minute or up to 4 minutes. Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for 30 minutes. This topical foam con...

Storage and handling

Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For topical application to aid in the prevention of dental caries.

Treatment frequency should not exceed 4 treatments per year.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Shake can thoroughly for at least 10 seconds before each use.

Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Dry tooth surface and insert tray(s) into mouth. Have patient bite down for 1 minute or up to 4 minutes.

Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for 30 minutes.

DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

This topical foam contains 1.23% fluoride ion.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.

WARNINGS AND PRECAUTIONS

WARNINGS SECTION

Do not swallow. Harmful if swallowed.
Keep out of reach of children.
Contents under pressure. Do not puncture or incinerate can.
This product is not intended for home or unsupervised consumer use.
Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.

OVERDOSAGE

OVERDOSAGE SECTION

If treatment dose is swallowed (less than 100 mg F), administer milk, limewater, or calcium-type antacid. In case of larger doses (1 pint contains 4.5 grams F ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help.

Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticarial, gastric distress, headache, and weakness.

INGREDIENTS

SPL UNCLASSIFIED SECTION

Purified Water, Heptafluoropropane (Propellant), Denatured Ethyl Alcohol (Benzaldehyde), Sodium Fluoride, Crodafos 03A-LQ, Polyethylene Glycol 400, Crodafos MCASA-PA, Cetyl Alcohol, Sodium Methyl Cocoyl Taurate, Sodium Phosphate Monobasic Monohydrate, Artificial Bubble Gum Flavor, Sodium Saccharin, Sodium Benzoate

STORAGE

STORAGE AND HANDLING SECTION

Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]

SPL UNCLASSIFIED SECTION

Made in U.S.A.
0531152LA, R2-012018

PRINCIPAL DISPLAY PANEL - 125 g Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PATTERSON^®
DENTAL

NDC# 50227-0521-6

Patterson^® 60-Second
Foam Fluoride

(APF*) Topical Fluoride Solution
*Acidulated Phosphate Fluoride
1.23% Fluoride Ion (pH 3.5)

Bubble Gum

NET WT. 4.4 OZ (125 g)

Rx Only

Reorder Number
088-6135

Manufactured for:
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120

Danger: Extremely flammable aerosol.
Contains gas under pressure; may explode
if heated.
May cause an allergic skin reaction.
Causes serious eye damage.

PRINCIPAL DISPLAY PANEL - 125 g Canister Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
248389	sodium fluoride 2.72 % Oral Foam	PSN	2
248389	sodium fluoride 27.2 MG/ML Oral Foam	SCD	2
248389	sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral Foam	SY	2
248389	sodium fluoride 2.72 % Oral Foam	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50227-0521-6	2021-01-29	C162847	48780-1	ba0f9c33-2e05-a910-e053-dadaa90a0b85	Patterson ® 60-Second Foam Fluoride Bubble Gum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50227-0521-6	Topical 60 Sec Sodium Fluoride Bubble Gum	1 in 1 BOX	AEROSOL, FOAM	1		2
50227-0521-6	Topical 60 Sec Sodium Fluoride Bubble Gum	125 g in 1 CANISTER	AEROSOL, FOAM	125		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50227-0521	TOPICAL 60 SEC SODIUM FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]	2	Legacy NDC, 2 package rows	20190108_0712e427-d36d-4666-b2d8-48d747b4040e.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
APAFLURANE	INACTIVE INGREDIENT	R40P36GDK6	1
Benzaldehyde	INACTIVE INGREDIENT	TA269SD04T	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
CETYL PHOSPHATE	INACTIVE INGREDIENT	VT07D6X67O	1
OLETH-3 PHOSPHATE	INACTIVE INGREDIENT	8Q0Z18J1VL	1
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM METHYL COCOYL TAURATE	INACTIVE INGREDIENT	JVL98CG53G	1
Sodium Phosphate, Monobasic, Monohydrate	INACTIVE INGREDIENT	593YOG76RN	1

Products#

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

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

Topical 60 Sec Sodium Fluoride Bubble Gum
Sodium Fluoride
Fluoride Ion
SACCHARIN SODIUM
Sodium Benzoate
SODIUM METHYL COCOYL TAURATE
Polyethylene Glycol 400
CETYL PHOSPHATE
Cetyl Alcohol
OLETH-3 PHOSPHATE
Sodium Phosphate, Monobasic, Monohydrate
APAFLURANE
Benzaldehyde

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50227-0521	50227-0521-6

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
Sodium Fluoride	8ZYQ1474W7	ACTIB
SACCHARIN SODIUM	SB8ZUX40TY	IACT
Sodium Benzoate	OJ245FE5EU	IACT
SODIUM METHYL COCOYL TAURATE	JVL98CG53G	IACT
Polyethylene Glycol 400	B697894SGQ	IACT
CETYL PHOSPHATE	VT07D6X67O	IACT
Cetyl Alcohol	936JST6JCN	IACT
OLETH-3 PHOSPHATE	8Q0Z18J1VL	IACT
Sodium Phosphate, Monobasic, Monohydrate	593YOG76RN	IACT
APAFLURANE	R40P36GDK6	IACT
Benzaldehyde	TA269SD04T	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 3 · 165 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRAVITREAL	0.86 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	CAPSULE / ORAL	600 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL		104 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / TOPICAL	0.46 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / OPHTHALMIC	0.04 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	LOTION / TOPICAL		8 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.61 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SYRUP / ORAL	20.6 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Phosphate, Monobasic, Monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRAVITREAL	0.04 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 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
4eb21b38-5a0d-46e6-aa50-4671eeee5ebc			0712e427-d36d-4666-b2d8-48d747b4040e	2018-12-20	Warnings, Adverse reactions	Exact identifier spl id: 4eb21b38-5a0d-46e6-aa50-4671eeee5ebc spl set id: 0712e427-d36d-4666-b2d8-48d747b4040e

Reported adverse events (FAERS/openFDA)#

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