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Acclean 60 Second Fluoride Treatment Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: foam
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Apr 1, 2021.

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

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ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:0404-1731-44 125 g in 1 CANISTER
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 LABEL 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
1 NDC:0404-1711-44 125 g in 1 CANISTER
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 LABEL 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
1 NDC:0404-1701-44 125 g in 1 CANISTER
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 LABEL 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
1 NDC:0404-1721-44 125 g in 1 CANISTER
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 LABEL 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
1 NDC:0404-1741-44 125 g in 1 CANISTER
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)
Henry Schein

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