Label: COLGATE ULTRA RELIEF- sodium fluoride and potassium nitrate paste, dentifrice

  • NDC Code(s): 35000-992-21
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 19, 2020

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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, Glycerin, Hydrated Silica, Sorbitol, PEG-12, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Trisodium Phosphate, Poloxamer 407, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Blue 1.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE CO.
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    Colgate®
    Anticavity Toothpaste for Sensitive Teeth

    ULTRA
    RELIEF

    Relieves tooth sensitivity + Strengthens enamel
    gel

    NET WT 2.1 OZ (60 g)

    PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE ULTRA RELIEF 
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-992
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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:35000-992-211 in 1 CARTON10/16/2020
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02210/16/2020
    Labeler - Colgate-Palmolive Company (001344381)
    Registrant - Mission Hills, S.A. de C.V. (812312122)
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