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

  • NDC Code(s): 65954-044-60
  • Packager: Mission Hills S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 3, 2010

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  • SPL UNCLASSIFIED SECTION

    Drugs Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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 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, sorbitol, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin, xanthan gum, titanium dioxide

  • Questions or comments?

    call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022 Made in Mexico
    www.colgatesensitive.com

  • PRINCIPAL DISPLAY PANEL - 170 g Carton

    Colgate®
    Toothpaste for Sensitive Teeth and Cavity Protection

    Clinically Proven
    Sensitivity Relief

    NET WT 6.0 OZ (170 g)

    MAXIMUM STRENGTH*

    Sensitive
    enamelprotect

    ✓
    Helps Protect Against Acid Wear
    ✓
    Hardens Enamel
    Principal Display Panel - 170 g Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE   SENSITIVE ENAMEL PROTECT
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-044
    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) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 122.97 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9) 16 mg  in 1 g
    SORBITOL (UNII: 506T60A25R) 363 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) 200 mg  in 1 g
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) 30 mg  in 1 g
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) 5 mg  in 1 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 39.99 mg  in 1 g
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 6.9 mg  in 1 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 9 mg  in 1 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 2.7 mg  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE) 2 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 5 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-044-601 in 1 CARTON
    1170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/30/2010
    Labeler - Mission Hills S.A. de C.V. (812312122)
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