Sodium Fluoride 5000 ppm Enamel Protect SODIUM FLUORIDE1.1% POTASSIUM NITRATE 5% SHEFFIELD PHARMACEUTICALS LLC FDA Approved Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
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Substance Potassium Nitrate
Route
DENTAL
Package NDC

Drug Facts

Composition & Profile

Inactive Ingredients
Inactive Ingredients: carrageenan cocamidopropyl betaine flavor hydrated silica PEG-12 poloxamer 407 sodium hydroxide sodium lauryl sulfate sodium saccharin sorbitol titanium dioxide water xanthan gum
Strengths
100 ml
Quantities
100 ml
Treats Conditions
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
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
RU45X2JN0Z 8ZYQ1474W7
Packaging

HOW SUPPLIED: Mint 3.4 FL OZ (100 mL) tube NDC 11527-745-34 STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C).; PRINCIPAL DISPLAY PANEL - 100 mL Tube Wentworth NDC 11527-745-34 Sodium Fluoride 5000 ppm MINT ENAMEL PROTECT 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength Toothpaste for Sensitive Teeth 3.4 FL OZ (100 mL) RX ONLY Wentworth Enamel Protect Tube.jpg; PRINCIPAL DISPLAY PANEL - 100 mL Carton Wentworth NDC 11527-745-34 Sodium Fluoride 5000 ppm MINT ENAMEL PROTECT 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength Toothpaste for Sensitive teeth 3.4 FL OZ (100 mL) RX ONLY Wentworth Enamel Protect Carton.jpg

Package Descriptions
  • HOW SUPPLIED: Mint 3.4 FL OZ (100 mL) tube NDC 11527-745-34 STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C).
  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Wentworth NDC 11527-745-34 Sodium Fluoride 5000 ppm MINT ENAMEL PROTECT 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength Toothpaste for Sensitive Teeth 3.4 FL OZ (100 mL) RX ONLY Wentworth Enamel Protect Tube.jpg
  • PRINCIPAL DISPLAY PANEL - 100 mL Carton Wentworth NDC 11527-745-34 Sodium Fluoride 5000 ppm MINT ENAMEL PROTECT 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength Toothpaste for Sensitive teeth 3.4 FL OZ (100 mL) RX ONLY Wentworth Enamel Protect Carton.jpg

Overview

Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Indications & 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.)

Dosage & Administration

: Follow these instructions unless otherwise instructed by your dental professional: Adults and children 12 years of age and older: Apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.

Warnings & Precautions
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.
Contraindications

: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

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.

Storage & Handling

STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C).


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