TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY- sodium fluoride gel TOPEX NEUTRAL PH FLUORIDE GEL MINT- sodium fluoride gel

Topex Neutral pH Fluoride Gel by

Drug Labeling and Warnings

Topex Neutral pH Fluoride Gel by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC. Professional Division Trading as "Sultan Healthcare", Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL - Clearly Strawberry 16 oz bottle

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0702-16	495 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1900

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0701-16	495 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1900

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	Business Operations
Dentsply Caulk		083235549	manufacture(0699-0701, 0699-0702)