Label: COLGATE TOTAL WHITENING FRESH BOOST- stannous fluoride gel, dentifrice

  • NDC Code(s): 35000-179-48, 35000-179-65, 35000-179-66
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • 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 the 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, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Mica, Sucralose, Blue 1, Titanium Dioxide, Yellow 10.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

    Colgate®
    Anticavity, Antigingivitis and Antisensitivity Toothpaste

    Total

    24
    HR
    ANTIBACTERIAL
    PROTECTION†

    WHITENING
    + FRESH BOOST

    ADA
    Accepted
    American
    Dental
    Association ®

    ✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL
    ✓TARTAR ✓FRESH BREATH ✓WHITENS ✓SENSITIVITY RELIEF

    NET WT 5.1 OZ (144 g)

    GEL

    PRINCIPAL DISPLAY PANEL - 144 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL WHITENING FRESH BOOST 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-179
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-179-481 in 1 CARTON12/01/202112/30/2024
    1136 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-179-661 in 1 CARTON12/27/2021
    2144 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-179-652 in 1 CARTON11/26/2021
    3144 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02111/26/2021
    Labeler - Colgate-Palmolive Company (001344381)
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