Label: COLGATE TOTAL SF WHITENING- stannous fluoride paste, dentifrice

  • NDC Code(s): 35000-176-14, 35000-176-21, 35000-176-25, 35000-176-32, view more
    35000-176-33, 35000-176-48, 35000-176-60, 35000-176-65, 35000-176-66, 35000-176-78, 35000-176-95, 35000-176-96
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 10, 2023

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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 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, Tetrasoium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, 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 - 170 g Tube Carton

    Colgate®
    Anticavity, Antigingivitis and Antisensitivity Toothpaste

    ADA
    Accepted
    American
    Dental
    Association ®

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

    Total

    24
    HR
    ANTIBACTERIAL
    PROTECTION†

    WHITENING

    NET WT 6.0 OZ (170 g)
    PASTE

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL SF WHITENING 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-176
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-176-141 in 1 CARTON11/01/2018
    139 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-176-321 in 1 CARTON11/01/2018
    293 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-176-481 in 1 CARTON11/01/201812/30/2024
    3136 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-176-962 in 1 CARTON11/01/201812/30/2024
    4136 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-176-951 in 1 CARTON11/01/201812/31/2022
    5178 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:35000-176-781 in 1 CARTON11/01/201812/31/2022
    6221 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-176-251 in 1 CARTON01/15/2021
    724.9 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:35000-176-601 in 1 CARTON02/12/2021
    8170 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:35000-176-331 in 1 CARTON09/11/2021
    936.8 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:35000-176-652 in 1 CARTON12/01/2021
    10144 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:35000-176-661 in 1 CARTON12/27/2021
    11144 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:35000-176-211 in 1 CARTON11/17/2022
    1259 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/01/2018
    Labeler - Colgate-Palmolive Company (001344381)
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