Label: COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-916-60
  • Packager: Colgate-Palmolive Company
  • 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 4, 2019

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    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

    glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    COOL MINT

    Ultra brite®
    ANTICAVITY FLUORIDE TOOTHPASTE

    NET WT 6.0 OZ (170 g)

    DEEP CLEANS TEETH
    Baking Soda
    & Peroxide
    Whitening
    TOOTHPASTE

    PRINCIPAL DISPLAY PANEL - 170 g Tube Cartonl
  • INGREDIENTS AND APPEARANCE
    COLGATE   ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-916
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 491.6 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-916-601 in 1 CARTON12/01/2011
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/01/2011
    Labeler - Colgate-Palmolive Company (001344381)
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!