Label: COLGATE SENSITIVE COMPLETE PROTECTION- sodium fluoride and potassium nitrate paste, dentifrice

  • NDC Code(s): 35000-965-01, 35000-965-60, 35000-965-69
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Potassium nitrate 5%Antisensitivity
    Sodium fluoride 0.24% (0.14% w/v fluoride ion)Anticavity
  • Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • helps protect against cavities
  • Warnings

    When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    Stop use and ask a dentist if the 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.

  • Directions

    adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
    children under 12 yearsconsult a dentist or physician
  • Inactive ingredients

    water, hydrated silica, glycerin, sorbitol, PEG-12, tetrapotassium pyrophosphate, PVM/MA copolymer, flavor, sodium lauryl sulfate, poloxamer 407, sodium hydroxide, sodium saccharin, cellulose gum, xanthan gum, titanium dioxide

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    Colgate®
    Toothpaste for Sensitive Teeth and Cavity Protection

    8 Benefits

    ✓Sensitivity    ✓Tartar    ✓Freshens
    ✓Enamel      ✓Plaque** ✓Whitens
    ✓Cavities    ✓Gums**

    NET WT 6.0 OZ (170 g)

    NEW
    MAXIMUM STRENGTH*

    Sensitive

    Complete Protection

    Principal Display Panel - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE SENSITIVE COMPLETE PROTECTION 
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-965
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 189.046 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-965-601 in 1 CARTON12/18/2013
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-965-691 in 1 CARTON12/18/2013
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-965-011 in 1 CARTON12/18/2013
    328.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35612/18/2013
    Labeler - Colgate-Palmolive Company (001344381)
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