Label: CLINPRO TOOTH CREME- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.21% (0.12% w/v fluoride ion)

  • Purpose

    Anticavity Toothpaste

  • Use

    helps protect teeth and roots against cavities

  • Warnings

    Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing, use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
    • children under 2 years, ask your dentist
  • Inactive ingredients

    water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin, tri-calcium phoshate

  • Questions? 1-800-634-2249

  • Principal Display Panel

    NDC 48878-3150-4

    3M ESPE

    Clinpro™ Tooth Crème

    Vanilla Mint

    0.21% Sodium Flouride
    Anti-Cavity Toothpaste

    Contents: 1 Tube NET WT 4 oz (113 g)

    Principal Display Panel - Clinpro Tooth Creme

  • 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:48878-3150-41 in 1 BOX07/18/2013
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/18/2013
    Labeler - Solventum US OpCo LLC (801390852)
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