Wentworth Alcohol Free SODIUM FLUORIDE SHEFFIELD PHARMACEUTICALS LLC FDA Approved Wentworth Sodium Fluoride Rinse 0.2% of neutral sodium fluoride is a mint-flavored, neutral, aqueous solution. Active Ingredient Sodium Fluoride 0.2% (w/v) Inactive Ingredients benzoic acid, flavor, glycerin, poloxamer 338, propylene glycol, sodium benzoate, water, FD&C Blue No. 1
FunFoxMeds bottle
Substance Sodium Fluoride
Route
DENTAL
Package NDC

Drug Facts

Composition & Profile

Strengths
473 ml
Quantities
473 ml
Treats Conditions
Indications And Usage A Dental Caries Preventive For Weekly Self Applied Topical Use Weekly Rinsing With A Neutral 0 2 Sodium Fluoride Solution Protects Against Dental Caries In Adults And Pediatric Patients Wentworth Sodium Fluoride Rinse Provides A Ready To Use Preparation For Convenient Administration And Favorable Compliance May Be Used In Areas Where Drinking Water Is Fluoridated Since Topical Fluoride Cannot Produce Fluorosis See Warnings For Exception
Pill Appearance
Color: blue

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
8ZYQ1474W7
Packaging

HOW SUPPLIED Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 11527-735-16). STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C).; PRINCIPAL DISPLAY PANEL - 473 mL Rinse Label NDC 11527-735-16 Wentworth ® AlCOHOL FREE Sodium Fluoride Rinse 0.2% Neutral Sodium Fluoride Reduces cari es up to 55% 1 COOL MINT KEEP OUT OF REACH OF INFANTS AND CHILDREN 16 FL OZ (1 PT) 473 mL Rx ONLY Wentworth Sodium Fluoride Rinse Label.jpg; PRINCIPAL DISPLAY PANEL - 473 mL Carton Label NDC 11527-735-16 Wentworth ® AlCOHOL FREE Sodium Fluoride Rinse 0.2% Neutral Sodium Fluoride Reduces cari es up to 55% 1 COOL MINT KEEP OUT OF REACH OF INFANTS AND CHILDREN 16 FL OZ (1 PT) 473 mL Rx ONLY Wentworth Sodium Fluoride Rinse Carton.jpg

Package Descriptions
  • HOW SUPPLIED Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 11527-735-16). STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C).
  • PRINCIPAL DISPLAY PANEL - 473 mL Rinse Label NDC 11527-735-16 Wentworth ® AlCOHOL FREE Sodium Fluoride Rinse 0.2% Neutral Sodium Fluoride Reduces cari es up to 55% 1 COOL MINT KEEP OUT OF REACH OF INFANTS AND CHILDREN 16 FL OZ (1 PT) 473 mL Rx ONLY Wentworth Sodium Fluoride Rinse Label.jpg
  • PRINCIPAL DISPLAY PANEL - 473 mL Carton Label NDC 11527-735-16 Wentworth ® AlCOHOL FREE Sodium Fluoride Rinse 0.2% Neutral Sodium Fluoride Reduces cari es up to 55% 1 COOL MINT KEEP OUT OF REACH OF INFANTS AND CHILDREN 16 FL OZ (1 PT) 473 mL Rx ONLY Wentworth Sodium Fluoride Rinse Carton.jpg

Overview

Wentworth Sodium Fluoride Rinse 0.2% of neutral sodium fluoride is a mint-flavored, neutral, aqueous solution. Active Ingredient Sodium Fluoride 0.2% (w/v) Inactive Ingredients benzoic acid, flavor, glycerin, poloxamer 338, propylene glycol, sodium benzoate, water, FD&C Blue No. 1

Indications & Usage

A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. Wentworth Sodium Fluoride Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Dosage & Administration

For caries — Adults and pediatric patients over age 6 years, 2 teaspoons (10 mL). Once a week, preferably at bedtime after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.

Warnings & Precautions
WARNINGS Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING
Contraindications

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

Adverse Reactions

In patients with mucositis, gingival tissues may be hypersensitive to flavor present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.

Storage & Handling

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


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