Label: TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY- sodium fluoride gel
TOPEX NEUTRAL PH FLUORIDE GEL MINT- sodium fluoride gel
- NDC Code(s): 0699-0701-16, 0699-0702-16
- Packager: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS AND USAGE
-
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
- CONTRAINDICATIONS
-
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
- OVERDOSAGE
- DESCRIPTION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - Clearly Strawberry 16 oz bottle
-
INGREDIENTS AND APPEARANCE
TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY
sodium fluoride gelProduct 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 01/01/1974 08/18/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974 08/18/2023 TOPEX NEUTRAL PH FLUORIDE GEL MINT
sodium fluoride gelProduct 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 01/01/1974 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974 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)