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 — Mint 16 oz bottle

Mint
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Clearly Strawberry 16 oz bottle

strawberry
(click image for full-size original)

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 (SACCHARIN)
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 01/01/1900
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 (SACCHARIN)
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 01/01/1900
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: 11/2017 Dentsply LLC. Professional Division Trading as “Sultan Healthcare”

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