Topex Neutral PH Fluoride Gel Strawberry

TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY- fluoride ion gel
TOPEX NEUTRAL PH FLUORIDE GEL MINT- fluoride ion gel
Dentsply LLC. Professional Division Trading as “Sultan Healthcare”

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.

INDICATIONS AND USAGE

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. 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

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

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

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

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

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

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

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL — 480 mL Bottle Label

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 — Clearly Strawberry 16 oz bottle

TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0702 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 9 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS XANTHAN GUM SODIUM HYDROXIDE

Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0702-16 495 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974

TOPEX NEUTRAL PH FLUORIDE GEL MINT sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0701 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 9 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER D&C YELLOW NO. 10 FD&C BLUE NO. 1 SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS XANTHAN GUM SODIUM HYDROXIDE

Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0701-16 495 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974

Labeler — Dentsply LLC. Professional Division Trading as “Sultan Healthcare” (167087753)

Establishment
Name	Address	ID/FEI	Operations
Dentsply Caulk		083235549	MANUFACTURE (0699-0701), MANUFACTURE (0699-0702)

Revised: 01/2022 Dentsply LLC. Professional Division Trading as “Sultan Healthcare”