View Drug - PreviDent OrthoDefense
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PreviDent OrthoDefense

Generic: SODIUM FLUORIDE

100%
Basic Information
Manufacturer
Colgate Oral Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
99d37f3e-ac4f-4e8f-92e3-9b27d7632d35
Indications & Usage
INDICATIONS AND USAGE A dental caries preventive; for twice daily self-applied topical use.

PreviDent® 5000 Ortho Defense™ 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush.

This prescription toothpaste should be used twice daily in place of your 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 the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing.

Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis.

Pediatric patients under age 12 should be supervised in the use of this product.

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.