Label: COLGATE SENSITIVE WHITENING FRESH MINT- potassium nitrate and sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-922-18, 35000-922-46, 35000-922-60
  • 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 20, 2022

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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, PVM/MA copolymer, sodium lauryl sulfate, flavor, poloxamer 407, trisodium phosphate, sodium hydroxide, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    MAXIMUM STRENGTH*

    Colgate®
    Anticavity Toothpaste for Sensitive Teeth

    Sensitive

    WHITENING

    RELIEVES & WHITENS

    ✓
    CLINICALLY PROVEN SENSITIVITY RELIEF
    ✓
    SUPERIOR STAIN REMOVAL†

    Recyclable
    Tube

    NET WT 6.0 OZ (170 g)
    FRESH MINT
    gel

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE SENSITIVE WHITENING FRESH MINT 
    potassium nitrate and sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-922
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 202.62 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorWHITE, BLUEScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-922-181 in 1 CARTON10/16/2015
    151 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-922-601 in 1 CARTON10/16/2015
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-922-461 in 1 CARTON01/07/2019
    3130 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 FINALpart35610/16/2015
    Labeler - Colgate-Palmolive Company (001344381)
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