TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY- sodium fluoride gel TOPEX NEUTRAL PH FLUORIDE GEL MINT- sodium fluoride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Dentsply LLC. Professional Division Trading as "Sultan Healthcare"

INN (International Name):

FLUORIDE ION

Composition:

FLUORIDE ION 9 mg in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.

Authorization status:

unapproved drug other

Summary of Product characteristics

TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY- SODIUM FLUORIDE GEL
TOPEX NEUTRAL PH FLUORIDE GEL MINT- SODIUM FLUORIDE GEL
DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"
_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._
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TOPEX NEUTAL PH
NEUTRAL SODIUM FLUORIDE GEL
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.
Lab