Fluoride Foam

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (2.72 g)

Inactive Ingredients

Water Sucralose Xylitol Sodium Phosphate, Monobasic, Anhydrous Cocamidopropyl Betaine Strawberry Poloxamer 407 Peppermint Oil Spearmint Oil Methyl Salicylate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-10-29

Medication Information

Description

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Mint

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Section 42229-5

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

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.

Bubble Gum

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Strawberry

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

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.

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.

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 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 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

Structured Label Content

Mint

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Section 42229-5 (42229-5)

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

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.

Bubble Gum

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Strawberry

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Directions for Use (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.

Medical Ingredients

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Non Medical Ingredients (Non-Medical Ingredients)

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, strawberry flavor.

Principal Display Panel 125 G Can Label Mint (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 Bubble Gum (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 Strawberry (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Mint": "FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.", "42229-5": "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", "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.", "Bubble Gum": "FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.", "Strawberry": "FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.", "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.", "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.", "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 - 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 - 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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information