Topex 60 Second Fluoride Foam

Approved

Approval ID

60dca200-d977-5662-e053-2991aa0ade04

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 26, 2024

Manufacturers

FDA

Dentsply LLC. Professional Division Trading as "Sultan Healthcare"

DUNS: 167087753

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0699-0154

Product Classification

Generic Name

sodium fluoride

Product Specifications

Route of AdministrationDENTAL

Effective DateJanuary 26, 2024

FDA Product Classification

INGREDIENTS (13)

SODIUM FLUORIDEActive

Quantity: 27.3 mg in 1 g

Code: 8ZYQ1474W7

Classification: ACTIM

CETYL PHOSPHATEInactive

Code: VT07D6X67O

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCN

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

OLETH-3 PHOSPHATEInactive

Code: 8Q0Z18J1VL

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SODIUM METHYL COCOYL TAURATEInactive

Code: JVL98CG53G

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RN

Classification: IACT

BENZALDEHYDEInactive

Code: TA269SD04T

Classification: IACT

APAFLURANEInactive

Code: R40P36GDK6

Classification: IACT

sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0699-0151

Product Classification

Generic Name

sodium fluoride

Product Specifications

Route of AdministrationDENTAL

Effective DateJanuary 26, 2024

FDA Product Classification

INGREDIENTS (13)

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCN

Classification: IACT

OLETH-3 PHOSPHATEInactive

Code: 8Q0Z18J1VL

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM METHYL COCOYL TAURATEInactive

Code: JVL98CG53G

Classification: IACT

BENZALDEHYDEInactive

Code: TA269SD04T

Classification: IACT

SODIUM FLUORIDEActive

Quantity: 27.3 mg in 1 g

Code: 8ZYQ1474W7

Classification: ACTIM

CETYL PHOSPHATEInactive

Code: VT07D6X67O

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RN

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

APAFLURANEInactive

Code: R40P36GDK6

Classification: IACT

sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0699-0150

Product Classification

Generic Name

sodium fluoride

Product Specifications

Route of AdministrationDENTAL

Effective DateJanuary 26, 2024

FDA Product Classification

INGREDIENTS (13)

SODIUM FLUORIDEActive

Quantity: 27.3 mg in 1 g

Code: 8ZYQ1474W7

Classification: ACTIM

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

OLETH-3 PHOSPHATEInactive

Code: 8Q0Z18J1VL

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCN

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SODIUM METHYL COCOYL TAURATEInactive

Code: JVL98CG53G

Classification: IACT

CETYL PHOSPHATEInactive

Code: VT07D6X67O

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RN

Classification: IACT

BENZALDEHYDEInactive

Code: TA269SD04T

Classification: IACT

APAFLURANEInactive

Code: R40P36GDK6

Classification: IACT

sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0699-0152

Product Classification

Generic Name

sodium fluoride

Product Specifications

Route of AdministrationDENTAL

Effective DateJanuary 26, 2024

FDA Product Classification

INGREDIENTS (13)

SODIUM FLUORIDEActive

Quantity: 27.3 mg in 1 g

Code: 8ZYQ1474W7

Classification: ACTIM

CETYL PHOSPHATEInactive

Code: VT07D6X67O

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

OLETH-3 PHOSPHATEInactive

Code: 8Q0Z18J1VL

Classification: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCN

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM METHYL COCOYL TAURATEInactive

Code: JVL98CG53G

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RN

Classification: IACT

BENZALDEHYDEInactive

Code: TA269SD04T

Classification: IACT

APAFLURANEInactive

Code: R40P36GDK6

Classification: IACT

sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0699-0153

Product Classification

Generic Name

sodium fluoride

Product Specifications

Route of AdministrationDENTAL

Effective DateJanuary 26, 2024

FDA Product Classification

INGREDIENTS (13)

SODIUM FLUORIDEActive

Quantity: 27.3 mg in 1 g

Code: 8ZYQ1474W7

Classification: ACTIM

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

OLETH-3 PHOSPHATEInactive

Code: 8Q0Z18J1VL

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCN

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RN

Classification: IACT

SODIUM METHYL COCOYL TAURATEInactive

Code: JVL98CG53G

Classification: IACT

APAFLURANEInactive

Code: R40P36GDK6

Classification: IACT

BENZALDEHYDEInactive

Code: TA269SD04T

Classification: IACT

CETYL PHOSPHATEInactive

Code: VT07D6X67O

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

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Topex 60 Second Fluoride Foam

Products 5

sodium fluoride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

sodium fluoride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

sodium fluoride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

sodium fluoride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

sodium fluoride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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