SF 5000 Plus

Generic Name: sodium fluoride
Dosage Form: dental cream

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.

SF 5000 Plus 1.1% Sodium Fluoride - Prescription Dental Cream

SF 5000 Plus Description

Self-topical neutral fluoride dentifrice containing 1.1%  (w/w)  sodium fluoride for use as a  dental caries  preventive in adults and pediatric  patients.

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ACTIVE INGREDIENTS: 
Sodium Fluoride 1.1% (w/w)

INACTIVE INGREDIENTS:  Water, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium Pyrophosphate, Flavor, PEG 12, Sodium Lauryl Sulfate, Sodium Saccharin, Titanium Dioxide, Cellulose Gum, F D and C Blue No. 1.

SF 5000 Plus - 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 tooth enamel. 

Indications and Usage for SF 5000 Plus

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 SF 5000 Plus 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.)

Contraindications

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

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 the dental cream which could cause dental fluorosis.  Read directions carefully before using.  Keep out of reach of infants and children. 

Precautions

Not for systemic treatment.  DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight.  Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight.  In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight.  Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. 

Fluoride ion is not mutagenic in standard bacterial systems.  It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed.  In vivo data are conflicting.  Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. 

Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated.  Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water.  Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. 

Pregnancy

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 taratogen.  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 during in utero development may result in skeletal fluorosis, which becomes evident in childhood.  

Nursing Mothers

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 the 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. 

Pediatric Use

The use of SF 5000 Plus in pediatric age groups 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- 14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established.  Please refer to the CONTRAINDICATIONS and WARNINGS sections. 

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported. 

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue.  Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.  These symptoms may persist for 24 hours.  If less than 5 mg fluoride/kg body weight  (i.e., 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours.  If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce emesis, give orally soluble calcium (e.g., milk, calcium gluconate or calcium lactate solution) and immediately seek medical assistance.  For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. 

A treatment dose (a thin ribbon) of SF 5000 Plus contains 2.5 mg fluoride.  A 1.8 oz. tube contains 255 mg fluoride. 

SF 5000 Plus Dosage and Administration

Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of SF 5000 Plus to a toothbrush.  Brush thoroughly once daily for two minutes, preferably at bedtime. 2. After use, adults expectorate.  For best results, do not eat, drink, or rinse for 30 minutes.  Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

How is SF 5000 Plus Supplied

1.8 oz. (51 g) net wt. tube

NDC# 60258-150-01.

STORAGE

Store at Controlled Room Temperature, 20-25oC (68-77oF).

Rx Only

REFERENCES

1. Accepted Dental Therapeutics, Ed. 40, ADA, Chicago. P.405-407, 1984.  2. Englander HR, Keyes et al: JADA 75:638-644, 1967.  3. Englander HR, et al: JADA 78:783-787, 1969.  4. Englander HR, et al: JADA 83:354-358 1971.

Manufactured By: Sheffield Laboratories, New London, CT 06320

Manufactured For: Cypress Pharmaceutical, Inc., Madison, MS 39110

Rev. 01/03 P165




Product Label

Spearmint

Rx Only

NDC 60258-150-01

SF 5000 Plus

1.1% SODIUM FLUORIDE Prescription Dental Cream

5000 ppm Flouride Plus Mild Cleaning System

NET WT. 1.8 OZ. (51 g)

Description:

Self-topical neutral 1.1% sodium fluoride for use as a dental caries preventative in adults and pediatric patients.

Directions for daily use:

(unless otherwise instructed by your dental professional)

1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of SF 5000 Plus to toothbrush.  Brush thoroughly for two minutes, preferably at bedtime (or as directed).

2. After use, adults expectorate.  For best results, do not eat, drink or rinse for 30 minutes.  Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

This prescription dental cream may be used daily in place of your regular toothpaste based on the recommendation of your dental professional.

Precautions:  DO NOT SWALLOW.

As with all medications, keep out of reach of infants and children.

In case of accidental overdose, contact a poison control center and seek professional assistance immediately.

Store at controlled room temperature, 20°-25°C (68°-77°F).

To report a serious adverse event or obtain product information, call 1-800-856-4393.

See package insert for full product information.

Manufactured for:

Cypress Pharmaceutical, Inc., Madison, MS 39110

REV 11/10




Product Label

Spearmint

Rx Only

NDC 60258-150-01

SF 5000 Plus

1.1% SODIUM FLUORIDE Prescription Dental Cream

5000 ppm Fluoride Plus Mild Cleaning System

NET. WT. 1.8 OZ. (51 g)

Directions for daily use: (unless otherwise instructed by your dental professional)

1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of SF 5000 Plus to toothbrush.  Brush thoroughly for two minutes, preferably at bedtime (or as directed).

2. After use, adults expectorate.  For best results, do not eat, drink or rinse for 30 minutes.  Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

This prescription dental cream may be used daily in place of your regular toothpaste based on the recommendation of your dental professional.

Description:  Self-topical neutral 1.1% sodium fluoride for use as a dental caries preventative in adults and pediatric patients.

Precautions:  DO NOT SWALLOW.  As with all medications, keep out of reach of infants and children.


In case of accidental overdose, contact a poison control center and seek professional assistance immediately.

Store at controlled room temperature, 20°-25°C (68°-77°F).

To report a serious adverse event or obtain product information, call 1-800-856-4393.

See package insert for full product information.

Manufactured for:

Cypress Pharmaceutical, Inc., Madison, MS  39110

B0017 Rev 11/10




SF 5000 Plus  
1.1% sodium fluoride prescription dental cream cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60258-150
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 11 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
WATER  
SORBITOL  
GLYCERIN  
FD&C BLUE NO. 1  
CARBOXYMETHYLCELLULOSE SODIUM  
SACCHARIN SODIUM DIHYDRATE  
SILICON DIOXIDE  
SODIUM PYROPHOSPHATE  
POLYETHYLENE GLYCOL 600  
Product Characteristics
Color blue Score     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:60258-150-01 1 TUBE (TUBE) in 1 CARTON
1 51 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/12/1999
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Registrant - Cypress Pharmaceutical, Inc. (790248942)
Establishment
Name Address ID/FEI Operations
Faria Limited dba Sheffield Pharmaceuticals 151177797 manufacture(60258-150)
Revised: 09/2012
 
Cypress Pharmaceutical, Inc.
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