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