fluoride foam

fluoride foam
SPL v2
SPL
SPL Set ID 222b29dc-7ad0-4872-9922-970efad8b7a7
Route
dental
Published
Effective Date 2023-01-12
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

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

Description

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


Medication Information

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.

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

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

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.

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

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


Raw Label Data

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