Topex Neutral pH 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
3
Source
legacy-cache
Hydrated at
2026-08-01 21:18:17

Label at a glance#

ProductTopex Neutral pH Fluoride Gel Strawberry
Active ingredientFLUORIDE ION
Label structure11 sections

Indications and uses

Topex® Fluoride Gels 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. Treatment frequency should not exceed 4 treatments per year.

Dosage and administration

1. Remove cap from bottle, remove induction seal. DO NOT USE IF SEAL IS BROKEN. 2. Replace cap and shake well. 3. Fill applicator tray no more than 1/3 full with Fluoride gel. 4. Dry tooth surface and insert tray in mouth. 5. Use suction throughout treatment. 6. 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) 7. R...

Storage and handling

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

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Topex® Fluoride Gels 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.

Treatment frequency should not exceed 4 treatments per year.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

1. Remove cap from bottle, remove induction seal. DO NOT USE IF SEAL IS BROKEN.

2. Replace cap and shake well.

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

4. Dry tooth surface and insert tray in mouth.

5. Use suction throughout treatment.

6. 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)

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

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

DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

APF topical gel contains 2.59% 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.
May contain FD&C Yellow #5 & 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 AND HANDLING

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0699-0701-16
REF AD31130

Topex®
NEUTRAL pH
NEUTRAL SODIUM FLUORIDE GEL
Mint

Contains 2.0% Sodium Fluoride
(0.9% Fluoride Ion)
Rx Only

Sultan®

SultanHealthcare

CONTENTS: 16 FL OZ. (480mL)

PRINCIPAL DISPLAY PANEL - 480 mL Bottle LabelPRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

PRINCIPAL DISPLAY PANEL - Clearly Strawberry 16 oz bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

strawberrystrawberry

FDA-Initiated Inactive NDC Indexing#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0699-07010699-0701-16
0699-07020699-0702-16

Ingredients#

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Source Document#

Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b975e994-58fa-4fd5-970a-efe305f3bf2560ccbdf2-9440-3f1e-e053-2a91aa0ac9932022-01-18Warnings, Adverse reactionsExact identifier
spl set id: 60ccbdf2-9440-3f1e-e053-2a91aa0ac993

Reported adverse events (FAERS/openFDA)#

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