General Information

Henry Schein, Inc.

Acclean Foam Fluoride 60 Second Application

Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion)

Contains:

Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant.

Gluten free.

Indications

For topical application to aid in the protection against dental caries.

Warnings

Contens under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 50-80F. Keep from freezing. do not spray toward open flame.

Instructions For Use

Prior to each use, shake can thoroughly for at least 15 seconds.
To dispense, invert can completely upside down. Slowly depress nozzle to fill fluoride applicator tray (foam will expand slightly higher than fluoride tray).
Tooth surface must be dry prior to inserting tray(s) in mouth.
Insert tray(s) into mouth and have patient bite down for 1-4 minutes.
Remove tray(s) and have patient expectorate.
Advise patient not to eat, drink or rinse for 30 minutes after treatment.

Professional Use Only

Principal Display Panel

Package Label

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1731
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1731-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1711
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
BETAINE (UNII: 3SCV180C9W)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1711-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1701
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BETAINE (UNII: 3SCV180C9W)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1701-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1721
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1721-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1741
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (Cream)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1741-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021	03/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021	03/31/2023

Labeler - Henry Schein (012430880)

ACCLEAN Foam Fluoride 60 Second Application

General Information

Indications

Warnings

Instructions For Use

Principal Display Panel

ACCLEAN
Foam Fluoride
60 Second Application