Label: ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION- sodium fluoride aerosol, foam

  • NDC Code(s): 0404-1701-44, 0404-1711-44, 0404-1721-44, 0404-1731-44, view more
    0404-1741-44
  • Packager: Henry Schein
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated April 28, 2021

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  • 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

    0404-1701-44

  • Principal Display Panel

    0404-1711-44

  • Principal Display Panel

    0404-1721-44

  • Principal Display Panel

    0404-1731-44

  • Principal Display Panel

    0404-1741-44

  • INGREDIENTS AND APPEARANCE
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    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)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    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)  
    BETAINE (UNII: 3SCV180C9W)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    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 Product04/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/28/2021
    Labeler - Henry Schein (012430880)
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