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 more0699-0154-44
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS AND USAGE
-
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
- CONTRAINDICATIONS
-
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
- OVERDOSAGE
-
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
- MANUFACTURED FOR
- PRINCIPAL DISPLAY PANEL - Strawberry 4.4 oz
- PRINCIPAL DISPLAY PANEL - Spearmint 4.4 oz
- PRINCIPAL DISPLAY PANEL - Bubble Fun 4.4 oz
- PRINCIPAL DISPLAY PANEL - Grape 4.4 oz
- PRINCIPAL DISPLAY PANEL - Orange Cream 4.4 oz
-
INGREDIENTS AND APPEARANCE
TOPEX 60 SECOND FLUORIDE FOAM BUBBLE FUN
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0152 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.3 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor BUBBLE GUM (Bubble Fun) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-0152-44 1 in 1 BOX 01/01/1997 1 125 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997 TOPEX 60 SECOND FLUORIDE FOAM GRAPE
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0153 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.3 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-0153-44 1 in 1 BOX 01/01/1997 02/12/2018 1 125 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997 02/12/2018 TOPEX 60 SECOND FLUORIDE FOAM SPEARMINT
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0151 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.3 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor MINT (Spearmint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-0151-44 1 in 1 BOX 01/01/1997 1 125 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997 TOPEX 60 SECOND FLUORIDE FOAM ORANGE CREAM
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0154 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.3 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor ORANGE (Orange Cream) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-0154-44 1 in 1 BOX 01/01/1997 01/31/2022 1 125 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997 TOPEX 60 SECOND FLUORIDE FOAM STRAWBERRY
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0150 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.3 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-0150-44 1 in 1 BOX 01/01/1997 1 125 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997 Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753) Establishment Name Address ID/FEI Business Operations Sciarra Laboratories, Inc. 824900369 MANUFACTURE(0699-0151, 0699-0150, 0699-0152, 0699-0153, 0699-0154)