SF 5000 PLUS- 1.1% sodium fluoride prescription dental cream cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Cypress Pharmaceutical, Inc.

INN (International namn):

SODIUM FLUORIDE

Sammansättning:

FLUORIDE ION 5 mg in 1 g

Administreringssätt:

DENTAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

A dental caries preventive; for once daily self-applied topical use.  It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 SF 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush.  This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.  May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.) Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.  The use of SF 5000 Plus in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11- 14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients below the age

Produktsammanfattning:

1.8 oz. (51 g) net wt. tube NDC# 60258-150-01. You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Cypress Pharmaceutical, Inc. at 1-800-793-2145 or FDA at 1-800-FDA-1088 (Toll Free).

Bemyndigande status:

unapproved drug other

Produktens egenskaper

SF 5000 PLUS - 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM CREAM
CYPRESS PHARMACEUTICAL, INC.
_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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SF 5000 PLUS 1.1% SODIUM FLUORIDE - PRESCRIPTION DENTAL CREAM
DESCRIPTION
Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium
fluoride for use as a dental
caries preventive in adults and pediatric patients.
ACTIVE INGREDIENTS: Sodium Fluoride USP 1.1% (w/w)
INACTIVE INGREDIENTS: Purified Water, Sorbitol, Hydrated Silica,
Glycerin, Tetrapotassium
Pyrophosphate, Flavor, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum,
Sodium Saccharin, Titanium
Dioxide, FD&C Blue No. 1.
CLINICAL PHARMACOLOGY
Frequent topical applications to the teeth with preparations having a
relatively high fluoride content
increase tooth resistance to acid dissolution and enhance penetration
of the fluoride ion into tooth
enamel.
INDICATIONS AND USAGE
A dental caries preventive; for once daily self-applied topical use.
It is well established that 1.1%
sodium fluoride is safe and extraordinarily effective as a caries
preventive when applied frequently
with mouthpiece applicators.
SF 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily
applied onto a toothbrush. This prescription dental cream should be
used once daily in place of your
regular toothpaste unless otherwise instructed by your dental
professional. May be used whether or not
drinking water is fluoridated, since topical fluoride cannot produce
fluorosis. (See WARNINGS for
exception.)
CONTRAINDICATIONS
Do not use in pediatric patients under age 6 years unless recommended
by a dentist or physician.
WARNINGS
Prolonged daily ingestion may result in various degrees of dental
fluorosis in pediatric patients under
age 6 years, especially if the water fluoridation exceeds 0.6 ppm,
since younger pediatric patients
frequently cannot perform the brushing process without significan