Label: CREST COMPLETE MULTI-BENEFIT EXTRA WHITENING PLUS SCOPE ADVANCED FRESHNESS- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-897-08, 37000-897-58
  • 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 March 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 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 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
      • do not swallow
      • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
    • children under 2 yrs.: ask a dentist
  • Inactive ingredients

    sorbitol, water, hydrated silica, disodium pyrophosphate, flavor, sodium lauryl sulfate, sodium hydroxide, alcohol (0.9%), xanthan gum, sodium saccharin, glycerin, carbomer, poloxamer 407, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

    Crest®
    complete
    MULTI-

    BENEFIT™

    NET WT 8.2 OZ (232 g) FLUORIDE TOOTHPASTE

    EXTRA

    WHITENING+

    scpo e®

    ADVANCED

    FRESHNESS

    897

  • INGREDIENTS AND APPEARANCE
    CREST COMPLETE MULTI-BENEFIT  EXTRA WHITENING PLUS SCOPE ADVANCED FRESHNESS
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-897
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-897-081 in 1 CARTON12/26/2017
    1232 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-897-585 in 1 CELLO PACK12/26/2017
    21 in 1 CARTON
    2232 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/26/2017
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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