NUPRO 60 SECOND FLUORIDE FOAM (SODIUM FLUORIDE) AEROSOL, FOAM [DENTSPLY PROFESSIONAL]

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NUPRO 60 SECOND FLUORIDE FOAM (SODIUM FLUORIDE) AEROSOL, FOAM [DENTSPLY PROFESSIONAL]
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NDC 65222-110-44, 65222-113-44, 65222-114-44, 65222-115-44
Set ID 115ffee9-1398-4fe3-986e-433e0989b78b
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Dentsply Professional
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    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.]

  • 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 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

  • INGREDIENTS AND APPEARANCE
    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 CARTON04/01/1997
    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 other04/01/1997
    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 CARTON04/01/1997
    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 other04/01/1997
    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 CARTON04/01/1997
    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 other04/01/1997
    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 CARTON04/01/1997
    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 other04/01/1997
    Labeler - Dentsply Professional (144140845)
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