FDA.reportPublic FDA data

NUPRO 60 Second Fluoride Foam

Manufacturer
Dentsply Professional | Dentsply Sirona, Inc. | Sciarra Laboratories Inc
Effective date
2022-11-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:49:14

Label at a glance#

ProductNUPRO 60 Second Fluoride Foam
Active ingredientSODIUM FLUORIDE
Label structure14 sections

Indications and uses

For topical application to aid in the protection against dental caries.

Dosage and administration

Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Use one press per arch (foam will expand slightly to fill the tray). Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 1 minute or up to 4 minutes. Remove tray(s) and have patient expectorate excess. Instruct patien...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For topical application to aid in the protection against dental caries.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Use one press per arch (foam will expand slightly to fill the tray). Dry tooth surface and insert tray(s) in 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.

FigureFigure

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Hypersensitivity to fluoride. Acidulated Phosphate Fluoride should not be used for patients with porcelain, composite restorations and sealants.

PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Do not swallow. Keep out of reach of children.

Safety and effectiveness below 3 years of age has 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 Acidulated Phosphate Fluoride may dull porcelain, composite restorations, and sealants.

OVERDOSAGE

OVERDOSAGE SECTION

If treatment dose is swallowed (or less than 100 mg of Fluoride ion) administer milk, limewater, or calcium-type antacid. In case of larger doses swallowed (more than 100 mg of Fluoride ion) administer 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 6 years of age may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

HOW SUPPLIED

HOW SUPPLIED SECTION

2.73% sodium fluoride (1.23% fluoride ion) foam supplied in 4.4 fl.oz. aerosol container

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

Manufactured for:
DENTSPLY Professional
1301 Smile Way
York, PA 17404

1-800-989-8826

Made in U.S.A.

SPL UNCLASSIFIED SECTION

Danger: Extremely flammable aerosol.

Contains gas under pressure: may explode if heated.

May cause an allergic skin reaction. Causes serious eye damage.

SAFETY DATA SHEET is available on our website, www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826.

warnings imageswarnings images

PRINCIPAL DISPLAY PANEL - Bubble Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bubble gumbubble gum

PRINCIPAL DISPLAY PANEL - Orange Vanilla

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orange VanillaOrange Vanilla

PRINCIPAL DISPLAY PANEL - Spearmint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

spearmintspearmint

PRINCIPAL DISPLAY PANEL - Strawberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

strawberrystrawberry

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride IonACTIVE MOIETYQ80VPU408O1
ApafluraneINACTIVE INGREDIENTR40P36GDK61
BenzaldehydeINACTIVE INGREDIENTTA269SD04T1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
Cetyl PhosphateINACTIVE INGREDIENTVT07D6X67O1
Oleth-3 PhosphateINACTIVE INGREDIENT8Q0Z18J1VL1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQ1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
Sodium Methyl Cocoyl TaurateINACTIVE INGREDIENTJVL98CG53G1
Sodium Phosphate, Monobasic, MonohydrateINACTIVE INGREDIENT593YOG76RN1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65222-11065222-110-44
65222-11365222-113-44
65222-11465222-114-44
65222-11565222-115-44

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
APAFLURANER40P36GDK6IACT
BENZALDEHYDETA269SD04TIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CETYL PHOSPHATEVT07D6X67OIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
APAFLURANER40P36GDK6IACT
BENZALDEHYDETA269SD04TIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CETYL PHOSPHATEVT07D6X67OIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
APAFLURANER40P36GDK6IACT
BENZALDEHYDETA269SD04TIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CETYL PHOSPHATEVT07D6X67OIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML · Source PDF

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 · 191 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVASCULAR0.15 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRA-ARTICULAR14 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
36 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SOLUTION / INTRAVENOUS27 mgExact identifier — unii candidate
36 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / ORAL104 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
ApafluraneAPAFLURANER40P36GDK6AEROSOL, METERED / RESPIRATORY (INHALATION)98.02 %w/wExact identifier — unii candidate
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
BenzaldehydeBENZALDEHYDETA269SD04TSUSPENSION / ORAL0.6 mg/1mlExact identifier — unii candidate
2 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAMUSCULAR120 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / SOFT TISSUE13 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSPRAY, METERED / NASAL320 mgExact identifier — unii candidate
36 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
BenzaldehydeBENZALDEHYDETA269SD04TLOZENGE / ORAL31 mgExact identifier — unii candidate
2 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVENOUS120 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / OPHTHALMIC0.04 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / TOPICAL0.46 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium Phosphate, Monobasic, MonohydrateSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / ORAL1500 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dc22f86a-7d06-47f7-8506-1c5124b89389115ffee9-1398-4fe3-986e-433e0989b78b2022-11-07Warnings, Adverse reactionsExact identifier
spl id: dc22f86a-7d06-47f7-8506-1c5124b89389
spl set id: 115ffee9-1398-4fe3-986e-433e0989b78b

Reported adverse events (FAERS/openFDA)#

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