SF Gel

Not for systemic treatment.  DO NOT SWALLOW.

Pregnancy Category B.  It has been 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 or 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 in utero development may result in skeletal fluorosis which becomes evident in childhood.

It is not known if fluoride is excreted in human milk.  However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman.  Reduced milk production was reported in farm-raised fox when animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight).  No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. 

Follow these instructions unless otherwise instructed by your dental professional: 1. After brushing thoroughly with toothpaste, rinse as usual.  Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime.  2. After use, adults expectorate gel.  For the best results, do not eat, drink, or rinse for 30 minutes.  Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.

1. American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407 (1984).  2.  H.R. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967).  3.  H.R. Englander et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 78, 783-787 (1969).  4.  H.R. Englander et al., Incremental Rates of Dental Caries After Repeated Topical Sodium Fluoride Applications in Children With Lifelong Consumption of Fluoridated Water, JADA, 82, 354-358, (1971).

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).

Manufactured for: Cypress Pharmaceutical, Inc., Morristown, NJ 07960

P166 Rev. 6/2016

504433

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very upset stomach or throwing up.