Label: CREST COMPLETE PLUS SCOPE OUTLAST ULTRA- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-918-65
  • 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 4, 2021

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

  • 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 (0.7%), sodium saccharin, xanthan gum, glycerin, poloxamer 407, carbomer, 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 - 184 g Tube Carton

    Crest

    complete plus

    PREMIUM

    NET WT 6.5 OZ (184 g)

    ANTICAVITY FLUORIDE TOOTHPASTE

    scope ®
    OUTLAST®

    ULTRA

    69423918

  • INGREDIENTS AND APPEARANCE
    CREST COMPLETE PLUS  SCOPE OUTLAST ULTRA
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-918
    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
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    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)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-918-651 in 1 CARTON01/05/2021
    1184 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/05/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)