TruGuard 5000

: 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 TruGuard 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.)

CONTRA INDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 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 the cream which could cause dental fluorosis.

Read directions carefully before using. Keep out of reach of infants and children.

Pregnancy : Pregnancy Category B. It has shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size of fetal weight and did not increase the frequency of skeletal or visceral malformations.

Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects, Heavy exposure to fluoride during utero development may result in skeletal fluorosis, which becomes evident in childhood.

Allergic reaction and other idiosyncrasies have been rarely reported.