Label: CREST PRO-HEALTH ADVANCED W/EXTRA DEEP CLEAN- sodium fluoride rinse

  • NDC Code(s): 37000-866-01, 37000-866-02, 37000-866-03
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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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

  • Warning

    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, blue 1

  • Questions?

    1-800-285-9139

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

    866 LabelsALCOHOL FREE

    WITH FLUORIDE

    Crest®

    PRO-HEALTH™

    ADVANCED

    ANTICAVITY FLUORIDE MOUTHWASH

    STRONGER TEETH*

    FOR A HEALTHIER MOUTH

    WITH

    EXTRA DEEP CLEAN**

    IMPORTANT:

    Read directions

    for proper use.

    • KILLS BAD BREATH GERMS
    • HELPS PREVENT CAVITIES
    • STRENGTHENS ENAMEL
    • CLEANS TEETH & GUMS
    • FRESHENS BREATH

    500 mL

    (16.9 FL OZ)

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  ADVANCED W/EXTRA DEEP CLEAN
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-866
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-866-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2016
    2NDC:37000-866-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2016
    3NDC:37000-866-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/29/2016
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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