NUPRO 60 SECOND FLUORIDE FOAM- sodium fluoride aerosol, foam 
Dentsply Professional

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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NUPRO™
APF Fluoride Foams

Rx Only

INDICATIONS AND USAGE

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 patient not to eat, drink, or rinse for 30 minutes.

Figure

RECOMMENDED FREQUENCY

Not to exceed 4 treatments per year.

CONTRAINDICATIONS

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

PRECAUTIONS

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

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

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

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

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.]

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

1-800-989-8826

Made in U.S.A.

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 images

PRINCIPAL DISPLAY PANEL - Bubble Gum

bubble gum

PRINCIPAL DISPLAY PANEL - Orange Vanilla

Orange Vanilla

PRINCIPAL DISPLAY PANEL - Spearmint

spearmint

PRINCIPAL DISPLAY PANEL - Strawberry

strawberry

NUPRO 60 SECOND FLUORIDE FOAM 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-110
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
APAFLURANE (UNII: R40P36GDK6)  
BENZALDEHYDE (UNII: TA269SD04T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-110-441 in 1 CARTON04/01/199710/28/2022
1125 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/199710/28/2022
NUPRO 60 SECOND FLUORIDE FOAM 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-113
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
APAFLURANE (UNII: R40P36GDK6)  
BENZALDEHYDE (UNII: TA269SD04T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGE, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-113-441 in 1 CARTON04/01/199712/28/2022
1125 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/199712/28/2022
NUPRO 60 SECOND FLUORIDE FOAM 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-114
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
APAFLURANE (UNII: R40P36GDK6)  
BENZALDEHYDE (UNII: TA269SD04T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-114-441 in 1 CARTON04/01/199709/28/2022
1125 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/199709/28/2022
NUPRO 60 SECOND FLUORIDE FOAM 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-115
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
APAFLURANE (UNII: R40P36GDK6)  
BENZALDEHYDE (UNII: TA269SD04T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-115-441 in 1 CARTON04/01/199709/28/2022
1125 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/199709/28/2022
Labeler - Dentsply Professional (144140845)
Registrant - Dentsply Sirona, Inc. (102221942)
Establishment
NameAddressID/FEIBusiness Operations
Sciarra Laboratories Inc824900369MANUFACTURE(65222-110, 65222-113, 65222-114, 65222-115)

Revised: 11/2022
 
Dentsply Professional