Acclean Foam Fluoride 60 Second Application

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION- sodium fluoride aerosol, foam
Henry Schein

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.

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

Principal Display Panel

Principal Display Panel

Principal Display Panel

Principal Display Panel

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS BETAINE POLOXAMER 407 SUCRALOSE XYLITOL

Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-1731-44 125 g in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g

Inactive Ingredients Ingredient Name Strength BETAINE SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS POLOXAMER 407

Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-1711-44 125 g in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g

Inactive Ingredients Ingredient Name Strength SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS BETAINE POLOXAMER 407

Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-1701-44 125 g in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g

Inactive Ingredients Ingredient Name Strength POLOXAMER 407 XYLITOL SUCRALOSE SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS BETAINE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-1721-44 125 g in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g

Inactive Ingredients Ingredient Name Strength POLOXAMER 407 XYLITOL SUCRALOSE SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS BETAINE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-1741-44 125 g in 1 CANISTER None

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

Labeler — Henry Schein (012430880)

Revised: 04/2021 Henry Schein