Label: CLINPRO TOOTH CREME- sodium fluoride paste, dentifrice

  • NDC Code(s): 48878-3150-1, 48878-3150-2, 48878-3150-5
  • Packager: Solventum US OpCo LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated April 1, 2024

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  • Principal Display Panel - 24g Carton Label

    3M ESPE

    Clinpro™ Tooth Crème

    0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

    24g

    Vanilla Mint

    Principal Display Panel - 24g Carton Label
  • Principal Display Panel – 24g Tube Label

    3M ESPE

    Clinpro™ Tooth Crème

    0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

    24g

    Vanilla Mint

    Principal Display Panel – 24g Tube Label
  • Principal Display Panel - 90 mL Carton Label

    3M ESPE

    Clinpro™ Tooth Crème

    0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate (950 ppm F-)

    90 ml

    Vanilla Mint

    Principal Display Panel - 90 mL Carton Label
  • Principal Display Panel - 90 mL Tube Label

    3M ESPE

    Clinpro™ Tooth Crème

    0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate (950 ppm F-)

    90 ml

    Vanilla Mint

    Principal Display Panel - 90 mL Tube Label
  • Principal Display Panel - 113g Carton Label

    3M ESPE

    Clinpro™ Tooth Crème

    0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

    113g

    Vanilla Mint

    Principal Display Panel - 113g Carton Label
  • Principal Display Panel - 113g Tube Label

    3M ESPE

    Clinpro™ Tooth Crème

    0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

    113g

    Vanilla Mint

    Principal Display Panel - 113g Tube Label
  • INGREDIENTS AND APPEARANCE
    CLINPRO TOOTH CREME 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.950 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Tricalcium Phosphate (UNII: K4C08XP666)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48878-3150-11 in 1 BOX12/20/2010
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:48878-3150-21 in 1 BOX12/20/2010
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:48878-3150-51 in 1 BOX12/20/201001/31/2022
    390 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/20/2010
    Labeler - Solventum US OpCo LLC (801390852)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(48878-3150)