Label: COLGATE ENAMEL HEALTH SENSITIVITY RELIEF- potassium nitrate and sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-206-20, 35000-206-26, 35000-206-60, 35000-206-69
  • Packager: Colgate-Palmolive
  • 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 October 7, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Potassium nitrate 5%Antisensitivity
    Sodium fluoride 0.24% (0.15% 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 2 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, sorbitol, hydrated silica, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, microcrystalline cellulose, zinc phosphate, cellulose gum, cocamidopropyl betaine, benzyl alcohol, sodium saccharin, xanthan gum, mica, 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

    Colgate®
    Anticavity Toothpaste for Sensitive Teeth

    ENAMEL
    HEALTH

    SENSITIVITY RELIEF

    STRENGTHEN & REPLENISH

    STRENGTHENS ENAMEL 4X BETTER
    HELPS REPLENISH NATURAL CALCIUM

    NET WT 6.0 OZ (170 g)
    FRESH MINT gel

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE ENAMEL HEALTH SENSITIVITY RELIEF 
    potassium nitrate and sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-206
    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)  
    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)  
    ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-206-201 in 1 CARTON06/30/201409/30/2023
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-206-691 in 1 CARTON06/30/201409/30/2023
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-206-261 in 1 CARTON06/30/201409/30/2023
    3155 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-206-601 in 1 CARTON11/30/201709/30/2023
    4170 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 FINALpart35606/30/201409/30/2023
    Labeler - Colgate-Palmolive (001344381)