Label: CREST PRO-HEALTH ADVANCED ANTI-CAVITY MAX CAVITY- sodium fluoride rinse

  • NDC Code(s): 69423-848-01, 69423-848-10, 69423-848-50
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

  • Purpose

    Anticavity

  • Use

    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, glycerin, flavor, poloxamer 407, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, sucralose, propylparaben, disodium phosphate, yellow 6, green 3

  • Questions?

    1–800–285–9139

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    + FLUORIDE

    Crest

    PRO-HEALTH

    ADVANCED

    ANTICAVITY FLUORIDE MOUTHWASH

    ALCOHOL FREE

    ANTI-CAVITY

    IMPORTANT:

    Read directions for proper use

    MAX CAVITY

    PROTECTION

    PROTECTS AGAINST CAVITIES

    REBUILDS WEAKENED ENAMEL

    STRENGTHENS TEETH

    CLEANS THE WHOLE MOUTH

    FRESHENS BREATH

    NO ALCOHOL BURN

    500 mL

    (16.9 fl oz)

    Label

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH ADVANCED  ANTI-CAVITY MAX CAVITY
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-848
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-848-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2020
    2NDC:69423-848-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2020
    3NDC:69423-848-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/31/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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