Label: CREST COMPLETE PLUS SCOPE INTENSE FRESHNESS- sodium fluoride rinse

  • NDC Code(s): 69423-709-03, 69423-709-33
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.02%
    (0.01% w/v fluoride ion)

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children. If more than used for
    rinsing is accidentally swallowed, get medical help or contact
    a Poison Control Center right away.

  • Directions

    • Adults and children 6 years & older:
      • Use twice a day after brushing your teeth with a toothpaste.
      • Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your
      teeth for 1 minute and then spit out. • Do not swallow the rinse.
      • Do not eat or drink for 30 minutes after rinsing.
      • Instruct children under 12 years of age in good rinsing habits
      (to minimize swallowing).
      • Supervise children as necessary until capable of using without supervision.
      • Children under 6 years of age: Consult a dentist or doctor.
  • Inactive ingredients

    water, alcohol (14.25 wt%), propylene glycol, flavor, benzoic acid, poloxamer
    407, cetylpyridinium chloride, sucralose, phosphoric acid, disodium phosphate, yellow 5, blue 1

  • Questions?

    1–800–285–9139

  • PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

    +FLUORIDE

    Crest

    complete

    plus Scope

    ANTICAVITY FLUORIDE

    MOUTHWASH

    ANTI-CAVITY

    +

    INTENSE FRESHNESS

    IMPORTANT: Read

    directions for proper use.

    SEE BACK FOR

    IMPORTANT

    INGREDIENT

    INFORMATION

    FRESH MINT

    1L (33.8 FL OZ)

    Label

  • INGREDIENTS AND APPEARANCE
    CREST COMPLETE PLUS SCOPE  INTENSE FRESHNESS
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-709
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-709-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/14/2011
    2NDC:69423-709-033 in 1 CELLO PACK03/14/2011
    21000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/14/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNLIT FLUO & CHEMICAL CO., LTD. CHUNG-LI FACTORY658870890api manufacture(69423-709)
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