Sodium Fluoride 5000 ppm Enamel Protect
Generic: SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%
Basic Information
Manufacturer
Sheffield Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
83dfdead-4f71-404e-90ae-dbd6849c7cf1
Indications & Usage
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing.
Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adults patients and children 12 years of age and older.
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 Sodium Fluoride 5000 ppm Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a tube is easily applied onto a toothbrush.
This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional.
May be in used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
(See WARNINGS for exception.)
Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adults patients and children 12 years of age and older.
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 Sodium Fluoride 5000 ppm Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a tube is easily applied onto a toothbrush.
This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional.
May be in used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
(See WARNINGS for exception.)
Warnings
WARNINGS: Not for systemic treatment- DO NOT SWALLOW.
Keep out of the reach of infants and children.
Children under 12 years of age, consult a dentist or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
See your dentist if the problem persists or worsens.
Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Keep out of the reach of infants and children.
Children under 12 years of age, consult a dentist or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
See your dentist if the problem persists or worsens.
Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Adverse Reactions
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.