Label: SF 5000 PLUS  - sodium fluoride cream 

  • NDC Code(s): 60258-150-01
  • Packager: Cypress Pharmaceutical, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 09/12

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  • 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.


    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.

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  • 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. 

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  • INDICATIONS AND USAGE

    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.)

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  • CONTRAINDICATIONS

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

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  • 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. 

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  • PRECAUTIONS

    Not for systemic treatment.  DO NOT SWALLOW.

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  • 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. 

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  • 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.  

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  • 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. 

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  • 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. 

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  • ADVERSE REACTIONS

    Allergic reactions and other idiosyncrasies have been rarely reported. 

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  • 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. 

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  • 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.

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  • HOW SUPPLIED

    1.8 oz. (51 g) net wt. tube

    NDC# 60258-150-01.

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  • STORAGE

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

    Rx Only

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  • 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

    SF 5000 Plus PI pg.1

    SF 5000 Plus PI pg.2


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  • 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

    SF 5000 Plus Tube Label



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  • 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 Package Label



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  • INGREDIENTS AND APPEARANCE
    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 Marketing Start Date Marketing End Date
    1 NDC:60258-150-01 1 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 Business Operations
    Faria Limited dba Sheffield Pharmaceuticals 151177797 manufacture(60258-150)
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