Label: TOPEX NEUTRAL FLUORIDE FOAM- sodium fluoride aerosol, foam
- NDC Code(s): 0699-0155-44
- Packager: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 26, 2024
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- Official Label (Printer Friendly)
- INDICATIONS AND USAGE
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DOSAGE AND ADMINSTRATION
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
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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
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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
- PRINCIPAL DISPLAY PANEL - Mixed Berry
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INGREDIENTS AND APPEARANCE
TOPEX NEUTRAL FLUORIDE FOAM
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0155 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) BENZALDEHYDE (UNII: TA269SD04T) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) CETYL ALCOHOL (UNII: 936JST6JCN) APAFLURANE (UNII: R40P36GDK6) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) DIETHANOLAMINE OLETH-10 PHOSPHATE (UNII: 55HSP2Q1LM) DIETHANOLAMINE OLETH-3 PHOSPHATE (UNII: Y67NX5905E) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Product Characteristics Color WHITE Score Shape Size Flavor BERRY (Mixed Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-0155-44 1 in 1 CARTON 01/01/1997 1 125 g in 1 CANISTER; 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(0699-0155)