Sodium Fluoride 5000 ppm Sensitive 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: Blue 1 Carrageenan Cocamidopropyl Betaine Flavor Hydrated Silica Mica PEG-12 Poloxamer 407 Sodium Hydroxide Sodium Laurryl Sulfate Sodium Saccharin Sorbitol Titanium Dioxide Water (purified) Yellow 10
Strengths
100 ml
Quantities
100 ml
Treats Conditions
Indications And Usage A Dental Caries Preventive And Sensitive Toothpaste For Twice Daily Self Applied Topical Use Following By Rinsing Helps Reduce The Painful Sensitivity Of The Teeth To Cold Heat Acid 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 Sensitive 1 1 Sodium Fluoride Toothpaste With 5 Potassium Nitrate In A Squeeze 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 Used Whether Or Not Drinking Water Is Fluoridated Since Topical Fluoride Cannot Produce Fluorosis See Warnings For Exception
Pill Appearance
Color: green

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
RU45X2JN0Z 8ZYQ1474W7
Packaging

HOW SUPPLIED: Mild Mint 3.4 floz. (100ml) net wt. tube NDC# 11527-704-42 STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).; PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-704-42 Sodium Fluoride 5000 ppm MILD MINT Sensitive 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength toothpaste for Sensitive Teeth 3.4 FLOZ (100ml) Rx only Wentworth Sensitive Tube.jpg; PRINCIPAL DISPLAY PANEL - 100 ml Carton Wentworth NDC 11527-704-42 Sodium Fluoride 5000 ppm MILD MINT Sensitive 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength toothpaste for Sensitive teeth 3.4 FLOZ (100ml) Rx only 544198-SH00145_Sensitve_Carton.jpg

Package Descriptions
  • HOW SUPPLIED: Mild Mint 3.4 floz. (100ml) net wt. tube NDC# 11527-704-42 STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).
  • PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-704-42 Sodium Fluoride 5000 ppm MILD MINT Sensitive 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength toothpaste for Sensitive Teeth 3.4 FLOZ (100ml) Rx only Wentworth Sensitive Tube.jpg
  • PRINCIPAL DISPLAY PANEL - 100 ml Carton Wentworth NDC 11527-704-42 Sodium Fluoride 5000 ppm MILD MINT Sensitive 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength toothpaste for Sensitive teeth 3.4 FLOZ (100ml) Rx only 544198-SH00145_Sensitve_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 toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, 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 Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-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 used whether or not 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 pediatric patients 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice daily, (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:consultant a dentist or physician.

Warnings & Precautions
WARNINGS: Not for systemic treatment- Do not Swallow. Keep out of the reach of 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, 20-25°C (68-77°F).


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