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Darby apf mint - Medication Information

Product NDC Code 66467-8004
Drug Name

Darby apf mint

Type Brand
Active Ingredients
Sodium fluoride 2.72 g/100g
Route DENTAL
Dosage Form AEROSOL, FOAM
RxCUI drug identifier 248389
Labeler Name Darby Dental Supply, LLC
Packages
Package NDC Code Description
66467-8004-2 125 g in 1 can (66467-8004-2)
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Description

General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Medical Ingredients Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride). Non-Medical Ingredients Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, strawberry flavor. Medical Ingredients Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride). Non-Medical Ingredients Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, mint flavor. Medical Ingredients Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride). Non-Medical Ingredients Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, bubble gum flavor.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions For Use l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment. Directions For Use l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment. Directions For Use l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Spl product data elements

Usually a list of ingredients in a drug product.
DARBY APF STRAWBERRY SODIUM FLUORIDE SODIUM FLUORIDE Fluoride Ion WATER Sucralose Xylitol SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE STRAWBERRY POLOXAMER 407 DARBY APF MINT SODIUM FLUORIDE SODIUM FLUORIDE Fluoride Ion WATER Sucralose Xylitol SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE Peppermint Oil Spearmint Oil POLOXAMER 407 DARBY APF BUBBLE GUM SODIUM FLUORIDE SODIUM FLUORIDE Fluoride Ion WATER Sucralose Xylitol SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE METHYL SALICYLATE POLOXAMER 407

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 125 g Can Label - Strawberry darby darby dental supply, llc TOPICAL FLUORIDE FOAM 2.72% TOPICAL SODIUM FLUORIDE FOAM 1.23% FLUORIDE IONS 130 Applications | 4.4 oz (125 g) Strawberry PRINCIPAL DISPLAY PANEL - 125 g Can Label - Strawberry PRINCIPAL DISPLAY PANEL - 125 g Can Label - Mint darby darby dental supply, llc TOPICAL FLUORIDE FOAM 2.72% TOPICAL SODIUM FLUORIDE FOAM 1.23% FLUORIDE IONS 130 Applications | 4.4 oz (125 g) Mint PRINCIPAL DISPLAY PANEL - 125 g Can Label - Mint PRINCIPAL DISPLAY PANEL - 125 g Can Label - Bubble Gum darby darby dental supply, llc TOPICAL FLUORIDE FOAM 2.72% TOPICAL SODIUM FLUORIDE FOAM 1.23% FLUORIDE IONS 130 Applications | 4.4 oz (125 g) Bubble Gum PRINCIPAL DISPLAY PANEL - 125 g Can Label - Bubble Gum

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Strawberry FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation. To reorder: Call 800.645.2310 or visit darby.com Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753 NDC 66467-8003∙2 Reorder# 9510050 1900196 Mint FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation. To reorder: Call 800.645.2310 or visit darby.com Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753 NDC 66467-8004∙2 Reorder# 9510051 1900197 Bubble Gum FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation. To reorder: Call 800.645.2310 or visit darby.com Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753 NDC 66467-8005∙2 Reorder# 9510052 1900198

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken. Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken. Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API