View Drug - PRO Gel 5000 Mint
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PRO Gel 5000 Mint

Generic: SODIUM FLUORIDE

100%
Basic Information
Manufacturer
DENTAL ALLIANCE HOLDINGS LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
f127e236-5207-948b-e053-2a95a90ab740
Indications & Usage
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)
Warnings
Warnings: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if water fluoridation exceeds 0.6 ppm.

Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel.

Read directions carefully before using.

Keep out of reach of infants and children.
Adverse Reactions
Adverse Reactions: Allergic reactions and other idiosyncrasies have been rarely reported.