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FDA Product

Topex Neutral pH Fluoride Gel Mint

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Topex Neutral pH Fluoride Gel Mint

0699-0701

Regulatory Information

0699-0701

January 18, 2022

Topex Neutal pHNeutral Sodium Fluoride Gel

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Dentsply LLC. Professional Division Trading as "Sultan Healthcare"

167087753

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: HHT01ZNK31

Class Code: IACT

FLUORIDE ION

Quantity: 9 mg in 1 g

Code: Q80VPU408O

Class Code: ACTIM

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

BENZOIC ACID

Code: 8SKN0B0MIM

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Code: 22ADO53M6F

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

Active Moieties

FLUORIDE ION

Code: Q80VPU408O

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