Topex 60 Second Fluoride Gel

Manufacturer
Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | Dentsply Caulk
Effective date
2022-01-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:13:30

Label at a glance#

ProductTopex 60 Second Fluoride Gel
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Storage and handling

Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.

Label contents#

Full prescribing information#

Indications & Usage

INDICATIONS & USAGE SECTION

For topical application to aid in the prevention of dental caries.

Treatment frequency should not exceed 4 treatments per year.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

1. DO NOT USE IF SEAL IS BROKEN. Shake well before using.

2. Fill applicator tray no more than 1/3 full with Fluoride gel.

3. Dry tooth surface and insert tray in mouth.

4. Use suction throughout treatment.

5. Have patient bite down for a minimum of 60 seconds to a maximum of 4 minutes. (A slight biting or chewing motion will provide interproximal coverage)

6. Remove tray and have patient expectorate excess gel. Do not swallow.

7. Instruct patient not to eat, drink, or rinse for 30 minutes after treatment.

Dosage Forms & Strengths

DOSAGE FORMS & STRENGTHS SECTION

This topical gel contains 1.23% sodium 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 & Precautions

WARNINGS AND PRECAUTIONS SECTION

  • Do not swallow. Harmful if swallowed.
  • Keep out of reach of children.
  • May contain FD&C Yellow #5 or FD&C Yellow #6.
  • This product is not intended for home or unsupervised consumer use.
  • 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), administer milk, limewater, or calcium-type antacid. In case of larger doses (1 pint contains 4.5 grams F ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help.

Description

DESCRIPTION SECTION

Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays.

Storage

STORAGE AND HANDLING SECTION

Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.

Principal display panel - Cherry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cherry labelCherry label

Principal Display Label - Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mint LabelMint Label

Principal Display Label - Orange Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orange LabelOrange Label

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0699-03110699-0311-16
0699-03120699-0312-16
0699-03170699-0317-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b8e901d-a029-4dfb-9329-80c8610eb14559039cf6-9007-7367-e053-2a91aa0a2fe92022-01-18Warnings, Adverse reactionsExact identifier
spl id: 3b8e901d-a029-4dfb-9329-80c8610eb145
spl set id: 59039cf6-9007-7367-e053-2a91aa0a2fe9

Reported adverse events (FAERS/openFDA)#

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