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

Topex 60 Second Fluoride Foam by

Drug Labeling and Warnings

Topex 60 Second Fluoride Foam by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC. Professional Division Trading as "Sultan Healthcare", Sciarra Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	27.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL PHOSPHATE (UNII: VT07D6X67O)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
BENZALDEHYDE (UNII: TA269SD04T)
APAFLURANE (UNII: R40P36GDK6)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0152-44	1 in 1 BOX	01/01/1997
1		125 g in 1 CAN; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	27.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
BENZALDEHYDE (UNII: TA269SD04T)
APAFLURANE (UNII: R40P36GDK6)
CETYL PHOSPHATE (UNII: VT07D6X67O)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0153-44	1 in 1 BOX	01/01/1997	02/12/2018
1		125 g in 1 CAN; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	27.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
APAFLURANE (UNII: R40P36GDK6)
CETYL PHOSPHATE (UNII: VT07D6X67O)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
BENZALDEHYDE (UNII: TA269SD04T)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0151-44	1 in 1 BOX	01/01/1997
1		125 g in 1 CAN; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	27.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL PHOSPHATE (UNII: VT07D6X67O)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
BENZALDEHYDE (UNII: TA269SD04T)
APAFLURANE (UNII: R40P36GDK6)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0154-44	1 in 1 BOX	01/01/1997
1		125 g in 1 CAN; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	27.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
CETYL PHOSPHATE (UNII: VT07D6X67O)
BENZALDEHYDE (UNII: TA269SD04T)
APAFLURANE (UNII: R40P36GDK6)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-0150-44	1 in 1 BOX	01/01/1997
1		125 g in 1 CAN; Type 0: Not a Combination Product

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	Business Operations
Sciarra Laboratories, Inc.		824900369	MANUFACTURE(0699-0151, 0699-0150, 0699-0152, 0699-0153, 0699-0154)