Label: COLGATE PROCLINICAL - SPARKLING MINT- sodium fluoride paste, dentifrice

  • 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 16, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Uses

    helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 years of age. 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, polyethylene, cocoamidopropyl betaine, sodium hydroxide, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1

  • Questions or comments?

    Call toll free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 113 g Carton

    Colgate®
    Anticavity Fluoride Whitening Toothpaste

    Paste

    PRO
    CLINICAL™
    white

    WHITER TEETH IN JUST 1 TUBE

    NET WT 4.0 OZ (113 g)

    Clinically Proven WHITENING TECHNOLOGY.

    Principal Display Panel - 113 g Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE PROCLINICAL - SPARKLING MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-543
    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
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
    Sodium Tripolyphosphate (UNII: 5HK03SA80J)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorWHITE (Blue Speckles) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51442-543-691 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/10/2010
    Labeler - Colgate-Palmolive Canada (259157246)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!