Label: TOPEX 60 SECOND FLUORIDE FOAM BUBBLE FUN- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM GRAPE- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM SPEARMINT- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM ORANGE CREAM- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM STRAWBERRY- sodium fluoride aerosol, foam

  • NDC Code(s): 0699-0150-44, 0699-0151-44, 0699-0152-44, 0699-0153-44, view more
    0699-0154-44
  • Packager: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated January 26, 2024

If you are a consumer or patient please visit this version.

  • INDICATIONS AND USAGE

    Topex® Fluoride Foams are indicated for topical application to teeth to aid in the prevention of dental caries.
    The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.

  • DOSAGE AND ADMINISTRATION

    1. Remove cap from can. If this is the first time using can, break the protective shipping tab by gently lifting up the trigger.

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

    3. Completely invert can and slowly depress trigger to dispense foam into a fluoride tray

    4. Air dry teeth thoroughly and insert tray into patient’s mouth. Have patient close into the tray and use a slight chewing motion to ensure interproximal coverage.

    5. Leave tray in contact with teeth between 1-4 minutes. Use a saliva ejector during treatment to minimize ingestion of product

    6. Remove tray after elapsed time and have patient expectorate. Instruct patient to refrain from drinking, eating, or rinsing for 30 minutes after treatment.

    Treatment frequency should not exceed 4 treatments per year.

  • DOSAGE FORMS AND STRENGTHS

    APF topical Foam contains 2.73% sodium fluoride (1.23% fluoride ion).

    NaF topical gel contains 2.0% sodium fluoride (0.9% fluoride ion).

  • CONTRAINDICATIONS

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

  • WARNINGS AND PRECAUTIONS

    Do not swallow. Harmful if swallowed.
    Keep out of reach of children.
    This product is not intended for home or unsupervised consumer use.
    Contents under pressure. Do not puncture or incinerate canister.
    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.

  • ADVERSE REACTIONS

    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.

  • OVERDOSAGE

    If treatment dose is swallowed (less than 100 mg F ion), administer milk, limewater, or calcium-type antacid. In case of larger doses, use ipecac syrup emetic and immediately seek medical help.Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.

  • DESCRIPTION

    Topex® Fluoride Foams are a family of topical fluoride foam products for professional application in trays. The family consists of APF Foam (1.23% fluoride ion at a pH between 3.0-4.5) and Neutral pH Foam (0.9% fluoride ion at a pH between 6.5 -7.5). Topex® Foam Fluoride products do not contain chlorofluorocarbon propellants.

  • 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.]

  • MANUFACTURED FOR

    Manufactured for:
    Sultan Healthcare
    1301 Smile Way • York, PA 17404 • USA
    T oll Free: 800-637-8582 • Phone: 201-871-1232
    Fax: 201-871-0321 • www.sultanhealthcare.com

    Made in USA

  • PRINCIPAL DISPLAY PANEL - Strawberry 4.4 oz

    strawberry

  • PRINCIPAL DISPLAY PANEL - Spearmint 4.4 oz

    spearmint

  • PRINCIPAL DISPLAY PANEL - Bubble Fun 4.4 oz

    bubble fun

  • PRINCIPAL DISPLAY PANEL - Grape 4.4 oz

    grape

  • PRINCIPAL DISPLAY PANEL - Orange Cream 4.4 oz

    orange cream

  • INGREDIENTS AND APPEARANCE
    TOPEX 60 SECOND FLUORIDE FOAM   BUBBLE FUN
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0152
    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
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    APAFLURANE (UNII: R40P36GDK6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBUBBLE GUM (Bubble Fun) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0152-441 in 1 BOX01/01/1997
    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 OTHER01/01/1997
    TOPEX 60 SECOND FLUORIDE FOAM   GRAPE
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0153
    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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    APAFLURANE (UNII: R40P36GDK6)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0153-441 in 1 BOX01/01/199702/12/2018
    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 OTHER01/01/199702/12/2018
    TOPEX 60 SECOND FLUORIDE FOAM   SPEARMINT
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0151
    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
    APAFLURANE (UNII: R40P36GDK6)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Spearmint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0151-441 in 1 BOX01/01/1997
    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 OTHER01/01/1997
    TOPEX 60 SECOND FLUORIDE FOAM   ORANGE CREAM
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0154
    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
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    APAFLURANE (UNII: R40P36GDK6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorORANGE (Orange Cream) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0154-441 in 1 BOX01/01/199701/31/2022
    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 OTHER01/01/1997
    TOPEX 60 SECOND FLUORIDE FOAM   STRAWBERRY
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0150
    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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    APAFLURANE (UNII: R40P36GDK6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0150-441 in 1 BOX01/01/1997
    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 OTHER01/01/1997
    Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sciarra Laboratories, Inc.824900369MANUFACTURE(0699-0151, 0699-0150, 0699-0152, 0699-0153, 0699-0154)