PRO-DEN RX- sodium fluoride rinse

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Tersedia dari:

Den-Mat Holdings, Llc

INN (Nama Internasional):

Sodium Fluoride

Komposisi:

Fluoride Ion 0.9 mg in 1 mL

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

For topical application to aid in the protection against dental caries. Neutral pH is especially safe for crowns and restorations. Hypersensitivity to fluoride.

Ringkasan produk:

2.0% Neutral Sodium Fluoride (0.9% Fluoride Ion) oral solution supplied in a plastic bottle with child-resistant closure containing 64 fl. oz. (1.89 L). Store at room temperature. Protect from freezing. Do not store in direct sunlight. Rx Only Revised: 12/2017 1-800-433-6628 Reorder Number: 2037MTDT Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 9343611 ©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

Status otorisasi:

unapproved drug other

Karakteristik produk

PRO-DEN RX- SODIUM FLUORIDE RINSE
DEN-MAT HOLDINGS, LLC
_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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2% FLUORIDE RINSE - DEN-MAT
INDICATIONS AND USAGE
For topical application to aid in the protection against dental
caries. Neutral pH is especially safe for
crowns and restorations.
DOSAGE AND ADMINISTRATION
Dispense ½ oz. (approx. 1 pump) of Pro-DenRx 2.0% Neutral Sodium
Fluoride Solution into the
provided mixing cup. Instruct patient to rinse vigorously for 30
seconds with ½ oz. of the solution
around and between teeth, then expectorate. For maximum benefit repeat
the rinse procedure with an
additional ½ oz. of solution. Pro-DenRx 2.0% Neutral Sodium Fluoride
Solution may also be applied
full strength, with cotton pledgets, to teeth isolated with cotton
rolls.
RECOMMENDED FREQUENCY
Do not exceed four (4) treatments per year.
CONTRAINDICATIONS
Hypersensitivity to fluoride.
WARNINGS AND PRECAUTIONS
For Professional Office Use Only. This product is not intended for
home or unsupervised consumer
use. Do not swallow. Keep out of reach of children. Not recommended
for children under the age of 6.
Limited to topical use in the mouth only.
ADVERSE REACTIONS
The following adverse reactions are possible in individuals
hypersensitive to fluoride: eczema, atopic
dermatitis, urticaria, gastric distress, headache, and weakness.
CAUTION
Federal law prohibits dispensing without a prescription.
OVERDOS AGE
Accidental ingestion of large amounts of fluoride can cause: nausea,
vomiting, abdominal pain, diarrhea,
stupor and/ or weakness (usually within 30 minutes). These symptoms
may persist for 24 hours. If less
than 5 mg fluoride/kg body weight (less than 23 mg fluoride/lb body
weight) has been ingested, give
calcium (milk) orally to relieve symptoms and observe for a few hours.
If more than 5 mg fluoride/kg
body weight (more than 23 mg fluoride/lb body weight) has been
ingested,