DARBY APF STRAWBERRY- sodium fluoride aerosol, foam DARBY APF MINT- sodium fluoride aerosol, foam DARBY APF BUBBLE GUM- sodium fluoride aerosol, foam

DARBY APF BUBBLE GUM by

Drug Labeling and Warnings

DARBY APF BUBBLE GUM by is a Prescription medication manufactured, distributed, or labeled by Darby Dental Supply, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

SPL UNCLASSIFIED SECTION

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.

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, mint flavor.

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.

SPL UNCLASSIFIED SECTION

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.

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, bubble gum flavor.

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.

SPL UNCLASSIFIED SECTION

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

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 - 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

INGREDIENTS AND APPEARANCE

DARBY APF STRAWBERRY 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66467-8003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.72 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Sucralose (UNII: 96K6UQ3ZD4)
Xylitol (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
STRAWBERRY (UNII: 4J2TY8Y81V)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-8003-2	125 g in 1 CAN; Type 0: Not a Combination Product	10/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/29/2019

DARBY APF MINT 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66467-8004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.72 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Sucralose (UNII: 96K6UQ3ZD4)
Xylitol (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Peppermint Oil (UNII: AV092KU4JH)
Spearmint Oil (UNII: C3M81465G5)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-8004-2	125 g in 1 CAN; Type 0: Not a Combination Product	10/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/29/2019

DARBY APF BUBBLE GUM 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66467-8005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.72 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Sucralose (UNII: 96K6UQ3ZD4)
Xylitol (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-8005-2	125 g in 1 CAN; Type 0: Not a Combination Product	10/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/29/2019

Labeler - Darby Dental Supply, LLC (825137818)