CTX4 GEL 5000 MINT- sodium fluoride gel, dentifrice CTX4 GEL 5000 CITRUS- sodium fluoride gel, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DENTAL ALLIANCE HOLDINGS LLC

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 5000 ug in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A dental caries preventive; for once daily self-applied topical use. It is well established that a 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 CariFree CTx4 Gel 5000 brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where 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 CariFree CTx4 Gel 5000 in pediatric age group 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 to 14 years conducted by Englander et al.2-4 Safety an

Product summary:

2 oz (56.699g) tube. NDC# 61578-205-01 (Mint) NDC# 61578-206-01 (Citrus)

Authorization status:

unapproved drug other

Summary of Product characteristics

CTX4 GEL 5000 MINT- SODIUM FLUORIDE GEL, DENTIFRICE
CTX4 GEL 5000 CITRUS- SODIUM FLUORIDE GEL, DENTIFRICE
DENTAL ALLIANCE 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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GEL 5000
DESCRIPTION:
Self-topical neutral fluoride gel containing 1.1% sodium fluoride for
use as a dental caries
preventive in adults and pediatric patients.
ACTIVE INGREDIENT:
Sodium Fluoride, 1.1% (w/w)
OTHER INGREDIENTS:
Glycerin, Hydrated Silica, Hydrogenated Starch Hydrolysate (HSH),
Hydroxyapatite,
Hydroxyethyl Cellulose, Natural Flavors (Mint only), Natural and
Artificial Flavors (Citrus
only), Polysorbate 20, Potassium Sorbate, Saccharin, Sodium Benzoate,
Sodium
Bicarbonate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, Xylitol
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 the tooth structure.
INDICATIONS AND USE:
A dental caries preventive; for once daily self-applied topical use.
It is well established
that a 1.1% sodium fluoride is safe and extraordinarily effective as a
caries preventive
when applied frequently with mouthpiece applicators.1-4 CariFree CTx4
Gel 5000 brand
of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied
onto a toothbrush
as well as a mouthpiece tray. This prescription dental gel should be
used once daily
following use of a regular toothpaste unless otherwise instructed by
your dental
professional. May be used in areas where 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.
physician.
WARNINGS:
Prolonged daily ingestion may result in various degrees of dental
fluorosis in pediatric
patients