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NDC 00699-0702-16 Topex Neutral pH Fluoride Gel 9 mg/g Details

Topex Neutral pH Fluoride Gel 9 mg/g

Topex Neutral pH Fluoride Gel is a DENTAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dentsply LLC. Professional Division Trading as "Sultan Healthcare". The primary component is FLUORIDE ION.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00699-0702-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	00699-0702
Product ID	0699-0702_b8fe24d4-7815-4bfb-bd9e-32406152ab4e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Topex Neutral pH Fluoride Gel
Proprietary Name Suffix	Strawberry
Non-Proprietary Name	sodium fluoride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	DENTAL
Active Ingredient Strength	9
Active Ingredient Units	mg/g
Substance Name	FLUORIDE ION
Labeler Name	Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00699-0702-16 (00699070216)

Pricing Information	N/A
NDC Package Code	0699-0702-16
Billing NDC	00699070216
Package	495 g in 1 BOTTLE (0699-0702-16)
Marketing Start Date	1974-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60ccbdf2-9440-3f1e-e053-2a91aa0ac993 Details

INDICATIONS AND USAGE

Topex® Fluoride Gels 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.

Treatment frequency should not exceed 4 treatments per year.

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

APF topical gel contains 2.59% 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.

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

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), administer milk, limewater, or calcium-type antacid. In case of larger doses (1 pint contains 4.5 grams F ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help.

DESCRIPTION

Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays.

STORAGE AND HANDLING

Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

NDC 0699-0701-16

REF AD31130

Topex®

NEUTRAL pH

NEUTRAL SODIUM FLUORIDE GEL

Mint

Contains 2.0% Sodium Fluoride

(0.9% Fluoride Ion)

Rx Only

Sultan®

SultanHealthcare

CONTENTS: 16 FL OZ. (480mL)

PRINCIPAL DISPLAY PANEL - Clearly Strawberry 16 oz bottle

INGREDIENTS AND APPEARANCE

TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY

sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0699-0702
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	9 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0699-0702-16	495 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1974

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		01/01/1974

TOPEX NEUTRAL PH FLUORIDE GEL MINT

sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0699-0701
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	9 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0699-0701-16	495 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1974

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		01/01/1974

Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)

Name	Address	ID/FEI	Business Operations
Establishment
Dentsply Caulk		083235549	MANUFACTURE(0699-0701, 0699-0702)

Revised: 1/2022

Document Id: b8fe24d4-7815-4bfb-bd9e-32406152ab4e

Set id: 60ccbdf2-9440-3f1e-e053-2a91aa0ac993

Version: 2

Effective Time: 20220118