Label: CREST 3D WHITE BRILLIANCE HYDROGEN PEROXIDE DEEP CLEAN- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 69423-790-30
  • Packager: The Procter & Gamble Manufacturing 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 June 2, 2023

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  • Drug Facts

    Sodium monofluorophosphate 1.14%

    (0.17% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • WARNINGS

  • Warning

    Keep out of reach of children under 12 yrs. 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 12 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    • do not swallow
    • children under 12 yrs.: ask a dentist
  • Inactive ingredients

    water, glycerin, calcium pyrophosphate, hydrogen peroxide (2.5% w/v), sodium lauryl sulfate, flavor, polyacrylate crosspolymer-6,
    cetearyl alcohol, disodium pyrophosphate, tetrasodium pyrophosphate, sucralose

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

  • Crest 3DWhite Advanced Hydrogen Peroxide 85 g tube in carton

    Crest 3DWhite Advanced HPCrest

    3DWhite

    FLUORIDE ANTICAVITY TOOTHPASTE

    ADVANCED

    HYDROGEN PEROXIDE

    2.5%

    WHITENS* AND DEEPLY CLEANS

    *by removing surface stains

    FRESH MINT

    ENAMEL SAFE WHITENING

    NET WT 3.0 OZ (85 g)

  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE BRILLIANCE HYDROGEN PEROXIDE DEEP CLEAN 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-790
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-790-301 in 1 CARTON06/15/2022
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02106/15/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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