Label: COLGATE TOTAL PLAQUE PRO RELEASE WHITENING- stannous fluoride paste, dentifrice

  • NDC Code(s): 35000-181-63
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 12, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

  • Purposes

    Anticavity, Antigingivitis, Antisensitivity

  • Uses

    • aids in the prevention of cavities
    • helps prevent gingivitis
    • helps interfere with harmful effects of plaque associated with gingivitis
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • Warnings

    When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

    Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
  • Directions

    • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
    • do not swallow.
    • children under 12 years of age: consult a dentist.
  • Other information

    • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
    • this Colgate product is specially formulated to help prevent staining.
  • Inactive ingredients

    Water, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Sodium Citrate, Arginine, Zinc Phosphate, PVM/MA Copolymer, Cellulose Gum, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Sucralose, Titanium Dioxide.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    Colgate®
    Anticavity, Antigingivitis and Antisensitivity Toothpaste

    Plaque
    PRO RELEASE
    with SMART FOAM®

    Dissolves & Lifts Away
    Gum Harming Plaque
    with Daily Brushing

    Total
    ACTIVE PREVENTION +

    NET WT 3.0 OZ (85 g)

    WHITENING
    PASTE

    CLINICALLY
    PROVEN

    ANTIBACTERIAL
    24
    HOUR1

    ✓Gingivitis ✓Plaque ✓Tartar ✓Sensitivity
    ✓Enamel Erosion ✓Stains ✓Bad Breath ✓Cavities

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL PLAQUE PRO RELEASE WHITENING 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-181
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ARGININE (UNII: 94ZLA3W45F)  
    ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
    METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (1750000 WAMW) (UNII: 9F20VSM0VU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-181-631 in 1 CARTON11/09/202209/30/2027
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02111/09/202209/30/2027
    Labeler - Colgate-Palmolive Company (001344381)
    Registrant - Colgate-Palmolive Company (785047999)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!