Label: ORAL B MINUTE-FOAM BUBBLE GUM- sodium fluoride solution
ORAL B MINUTE-FOAM MELLOW MINT- sodium fluoride solution
ORAL B MINUTE-FOAM ORANGE-A-TANGY- sodium fluoride solution
ORAL B MINUTE-FOAM STRAWBERRY- sodium fluoride solution
ORAL B MINUTE-FOAM GRAPE- sodium fluoride solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 3, 2023

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  • Description

    Minute-Foam® is a flavored aqueous foaming solution of acidulated phosphate sodium fluoride with an optimized low pH and a fluoride ion

    concentration of 1.23% w/w.

  • Inactives

    • Purified water
    • Poloxamer 407
    • Cocamidoprophyl betaine
    • Xylitol, sucralose
    • Sodiumphosphate monobasic
    • Flavor
  • Indication and Usage

  • Warnings

    •  DO NOT SWALLOW.
    • Keep out of reach of children. In the event more than the treatment dose is swallowed, administer calcium (e.g.milk) and get medical help or contact a Poison Control Center right away. Avoid spraying towards open flame.
    • Contents under pressure. Do not puncture or incinerate. Do not expose to heat.
    • Store at temperatures between 59-86°F
    • (15-30°C). Keep from freezing.
  • Product Label for Minute-Foam Bubble Gum

    bubble gum

  • Product Label for Minute-Foam Mellow Mint

    Mellow Mint

  • Product Label for Minute-Foam Orange-A-Tangy

    oragne

  • Product Label for Minute-Foam Strawberry

    strawberry

  • Product Label for Mint-Foam Grape

    grape

  • INGREDIENTS AND APPEARANCE
    ORAL B MINUTE-FOAM   BUBBLE GUM
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0345
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0345-06165 g in 1 BOTTLE; Type 0: Not a Combination Product11/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2014
    ORAL B MINUTE-FOAM   MELLOW MINT
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0341-06165 g in 1 BOTTLE; Type 0: Not a Combination Product11/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2014
    ORAL B MINUTE-FOAM   ORANGE-A-TANGY
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0342
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0342-06165 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2014
    ORAL B MINUTE-FOAM   STRAWBERRY
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0346
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0346-06165 g in 1 BOTTLE; Type 0: Not a Combination Product11/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2014
    ORAL B MINUTE-FOAM   GRAPE
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0347
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0347-06165 g in 1 BOTTLE; Type 0: Not a Combination Product11/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/201401/23/2018
    Labeler - YOUNG DENTAL MANUFACTURING CO 1, LLC (006309355)
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