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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 Oct 5, 2023.

Acclean 60 Second Fluoride Treatment Description

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 and Usage for Acclean 60 Second Fluoride Treatment

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

Warnings and Precautions

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 LabelPackage LabelPackage LabelPackage LabelPackage Label

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-1731
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
Product Characteristics
Color Score
ShapeSize
FlavorGRAPEImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-1731-44125 g in 1 CANISTER; Type 0: Not a Combination Product04/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/28/2021
ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-1711
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g in 1 g
Inactive Ingredients
Ingredient NameStrength
BETAINE (UNII: 3SCV180C9W)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
Product Characteristics
Color Score
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-1711-44125 g in 1 CANISTER; Type 0: Not a Combination Product04/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/28/2021
ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-1701
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BETAINE (UNII: 3SCV180C9W)
Product Characteristics
Color Score
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-1701-44125 g in 1 CANISTER; Type 0: Not a Combination Product04/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/28/2021
ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-1721
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g in 1 g
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)
Product Characteristics
Color Score
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-1721-44125 g in 1 CANISTER; Type 0: Not a Combination Product04/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/28/2021
ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-1741
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g in 1 g
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)
Product Characteristics
Color Score
ShapeSize
FlavorORANGE (Cream) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-1741-44125 g in 1 CANISTER; Type 0: Not a Combination Product04/28/202103/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/28/202103/31/2023
Labeler - Henry Schein (012430880)

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