Topex Neutral Fluoride Foam

Manufacturer
Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | Sciarra Laboratories, Inc.
Effective date
2024-01-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:12:24

Label at a glance#

ProductTopex Neutral Fluoride Foam
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

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.

Storage and handling

Store at 20°C - 25°C (68° - 77°F); excursions permitted between 15°C - 30°C (59° - 86°F) [See USP Controlled room temperature.]

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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 ADMINSTRATION

DOSAGE & ADMINISTRATION SECTION

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

DOSAGE FORMS & STRENGTHS SECTION

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

CONTRAINDICATIONS SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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

OVERDOSAGE SECTION

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

DESCRIPTION SECTION

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

STORAGE AND HANDLING SECTION

Store at 20°C - 25°C (68° - 77°F); excursions permitted between 15°C - 30°C (59° - 86°F) [See USP Controlled room temperature.]

PRINCIPAL DISPLAY PANEL - Mixed Berry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mixed berrymixed berry

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0699-01550699-0155-44

Ingredients#

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Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
22bf57b3-6915-4e6a-9e4c-312d3fa4093f60f08fe4-aace-c815-e053-2991aa0a3ded2025-03-05Warnings, Adverse reactionsExact identifier
spl set id: 60f08fe4-aace-c815-e053-2991aa0a3ded

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.