Label: COLGATE TOTAL GUM PROTECTION- stannous fluoride paste, dentifrice

  • NDC Code(s): 35000-572-32, 35000-572-48, 35000-572-96
  • Packager: Colgate-Palmolive
  • 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 November 5, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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, Tetrasodium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, 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 CO.
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - Two 136 g Tube Carton

    Colgate®
    Anticavity, Antigingivitis and Antisensitivity Toothpaste

    Recyclable
    Tube

    ✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL ✓TARTAR ✓FRESH BREATH
    ✓WHITENS ✓SENSITIVITY RELIEF ✓DEEP CLEAN ✓ODOR NEUTRALIZATION

    FIGHTS BACTERIA ON TEETH, TONGUE, CHEEKS AND GUMS

    2
    VALUE
    PACK

    Total
    WHOLE MOUTH HEALTH

    12
    HR
    ANTIBACTERIAL
    PROTECTION*

    STANNOUS FLUORIDE

    GUM
    PROTECTION
    Paste

    TWO 4.8 OZ (136 g) TUBES
    TOTAL NET WT 9.6 OZ (272 g)

    PRINCIPAL DISPLAY PANEL - Two 136 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL GUM PROTECTION 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-572
    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)  
    ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    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:35000-572-481 in 1 CARTON12/11/2020
    1136 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-572-962 in 1 CARTON12/21/2020
    2136 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-572-321 in 1 CARTON01/21/2021
    393 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/11/2020
    Labeler - Colgate-Palmolive (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company785047999ANALYSIS(35000-572) , LABEL(35000-572) , MANUFACTURE(35000-572) , PACK(35000-572)