DARBY APF STRAWBERRY- sodium fluoride aerosol, foam 
DARBY APF MINT- sodium fluoride aerosol, foam 
DARBY APF BUBBLE GUM- sodium fluoride aerosol, foam 
Darby Dental Supply, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FLUORIDE FOAM

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.

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.

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.

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 - 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
DARBY APF STRAWBERRY 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-8003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE2.72 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-8003-2125 g in 1 CAN; Type 0: Not a Combination Product10/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/29/2019
DARBY APF MINT 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-8004
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE2.72 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-8004-2125 g in 1 CAN; Type 0: Not a Combination Product10/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/29/2019
DARBY APF BUBBLE GUM 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-8005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE2.72 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-8005-2125 g in 1 CAN; Type 0: Not a Combination Product10/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/29/2019
Labeler - Darby Dental Supply, LLC (825137818)

Revised: 1/2023
Document Id: 41a2c0a1-baac-4a89-b8f7-b980c2a2f63f
Set id: 222b29dc-7ad0-4872-9922-970efad8b7a7
Version: 2
Effective Time: 20230112
 
Darby Dental Supply, LLC