Drugplain

SF 5000 Plus 5 mg/g

1.1% Sodium Fluoride Prescription Dental Cream · CREAM · Cypress Pharmaceutical, Inc.

No Recall History
Plain English

SF 5000 Plus is a cream containing 1.1% sodium fluoride prescription dental cream at 5 mg/g, taken dental. Manufactured by Cypress Pharmaceutical, Inc..

Key Facts

Brand Name
SF 5000 Plus
Generic Name
1.1% Sodium Fluoride Prescription Dental Cream
NDC Code (Product)
60258-150
Manufacturer
Cypress Pharmaceutical, Inc.
Strength
5 mg/g
Dosage Form
CREAM
Route
DENTAL
Marketing Status
Marketing Start
11/12/1999

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.)

Dosage & Administration

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.

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 the dental cream which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Contraindications

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

Adverse Reactions

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.

Frequently Asked Questions

What is SF 5000 Plus used for?

SF 5000 Plus contains 1.1% Sodium Fluoride Prescription Dental Cream. It is a cream taken dental. Consult your doctor for specific uses.

Is SF 5000 Plus a controlled substance?

SF 5000 Plus is not classified as a controlled substance by the DEA.

What is the generic name for SF 5000 Plus?

The generic name for SF 5000 Plus is 1.1% Sodium Fluoride Prescription Dental Cream. There are no other listed brand versions of 1.1% Sodium Fluoride Prescription Dental Cream.

What is the NDC code for SF 5000 Plus 5 mg/g?

The NDC (National Drug Code) for SF 5000 Plus 5 mg/g is 60258-150, listed by Cypress Pharmaceutical, Inc..

Product NDC

60258-150

Package NDC

60258-150-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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