Topex 60 Second Fluoride Foam Bubble Fun

TOPEX 60 SECOND FLUORIDE FOAM BUBBLE FUN- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM GRAPE- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM SPEARMINT- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM ORANGE CREAM- sodium fluoride aerosol, foam
TOPEX 60 SECOND FLUORIDE FOAM STRAWBERRY- sodium fluoride aerosol, foam
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 Foams 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.

DOSAGE AND ADMINISTRATION

1. Remove cap from can. If this is the first time using can, break the protective shipping tab by gently lifting up the trigger.

2. Shake can thoroughly for at least 10 seconds before each use.

3. Completely invert can and slowly depress trigger to dispense foam into a fluoride tray

4. Air dry teeth thoroughly and insert tray into patient’s mouth. Have patient close into the tray and use a slight chewing motion to ensure interproximal coverage.

5. Leave tray in contact with teeth between 1-4 minutes. Use a saliva ejector during treatment to minimize ingestion of product

6. Remove tray after elapsed time and have patient expectorate. Instruct patient to refrain from drinking, eating, or rinsing for 30 minutes after treatment.

Treatment frequency should not exceed 4 treatments per year.

DOSAGE FORMS AND STRENGTHS

APF topical Foam contains 2.73% 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.
This product is not intended for home or unsupervised consumer use.
Contents under pressure. Do not puncture or incinerate canister.
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 ion), administer milk, limewater, or calcium-type antacid. In case of larger doses, use ipecac syrup emetic and immediately seek medical help.Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.

DESCRIPTION

Topex® Fluoride Foams are a family of topical fluoride foam products for professional application in trays. The family consists of APF Foam (1.23% fluoride ion at a pH between 3.0-4.5) and Neutral pH Foam (0.9% fluoride ion at a pH between 6.5 -7.5). Topex® Foam Fluoride products do not contain chlorofluorocarbon propellants.

STORAGE AND HANDLING

Store at 20°C — 25°C (68°F — 77°F); excursions permitted between 15°C — 30°C (59°F — 86°F) [See USP Controlled room temperature.]

MANUFACTURED FOR

Manufactured for:
Sultan Healthcare
1301 Smile Way • York, PA 17404 • USA
T oll Free: 800-637-8582 • Phone: 201-871-1232 Fax: 201-871-0321 • www.sultanhealthcare.com

Made in USA

PRINCIPAL DISPLAY PANEL — Strawberry 4.4 oz

PRINCIPAL DISPLAY PANEL — Spearmint 4.4 oz

PRINCIPAL DISPLAY PANEL — Bubble Fun 4.4 oz

PRINCIPAL DISPLAY PANEL — Grape 4.4 oz

PRINCIPAL DISPLAY PANEL — Orange Cream 4.4 oz

TOPEX 60 SECOND FLUORIDE FOAM BUBBLE FUN sodium fluoride aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0152 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 27.3 mg in 1 g

Inactive Ingredients Ingredient Name Strength CETYL PHOSPHATE STEARIC ACID SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE APAFLURANE

Product Characteristics Color WHITE Score Shape Size Flavor BUBBLE GUM (Bubble Fun) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0152-44 1 CAN in 1 BOX contains a CAN 1 125 g in 1 CAN This package is contained within the BOX (0699-0152-44)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997

TOPEX 60 SECOND FLUORIDE FOAM GRAPE sodium fluoride aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0153 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 27.3 mg in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE APAFLURANE CETYL PHOSPHATE STEARIC ACID

Product Characteristics Color WHITE Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0153-44 1 CAN in 1 BOX contains a CAN 1 125 g in 1 CAN This package is contained within the BOX (0699-0153-44)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997 02/12/2018

TOPEX 60 SECOND FLUORIDE FOAM SPEARMINT sodium fluoride aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0151 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 27.3 mg in 1 g

Inactive Ingredients Ingredient Name Strength APAFLURANE CETYL PHOSPHATE SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE STEARIC ACID

Product Characteristics Color WHITE Score Shape Size Flavor MINT (Spearmint) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0151-44 1 CAN in 1 BOX contains a CAN 1 125 g in 1 CAN This package is contained within the BOX (0699-0151-44)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997

TOPEX 60 SECOND FLUORIDE FOAM ORANGE CREAM sodium fluoride aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0154 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 27.3 mg in 1 g

Inactive Ingredients Ingredient Name Strength CETYL PHOSPHATE STEARIC ACID SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE APAFLURANE

Product Characteristics Color WHITE Score Shape Size Flavor ORANGE (Orange Cream) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0154-44 1 CAN in 1 BOX contains a CAN 1 125 g in 1 CAN This package is contained within the BOX (0699-0154-44)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997

TOPEX 60 SECOND FLUORIDE FOAM STRAWBERRY sodium fluoride aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0150 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 27.3 mg in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE STEARIC ACID SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE CETYL PHOSPHATE BENZALDEHYDE APAFLURANE

Product Characteristics Color WHITE Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0150-44 1 CAN in 1 BOX contains a CAN 1 125 g in 1 CAN This package is contained within the BOX (0699-0150-44)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1997

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

Establishment
Name	Address	ID/FEI	Operations
Sciarra Laboratories, Inc.		824900369	MANUFACTURE (0699-0151), MANUFACTURE (0699-0150), MANUFACTURE (0699-0152), MANUFACTURE (0699-0153), MANUFACTURE (0699-0154)

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