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

  • NDC Code(s): 37000-867-01, 37000-867-02
  • 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

  • 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 12 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 12 years of age: consult a dentist or doctor.
  • Inactive ingredients

    water, glycerin, hydrogen peroxide, poloxamer 407, flavor, polysorbate 80, sodium saccharin, sucralose, phosphoric acid, disodium phosphate

  • Questions?

    1-800-285-9139

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    ALCOHOL FREE
    WITH FLUORIDE

    Crest®
    PRO-HEALTH™
    ADVANCED
    ANTICAVITY FLUORIDE MOUTHWASH

    STRONGER TEETH*
    FOR A HEALTHIER MOUTH

    WITH
    EXTRA WHITENING

    • KILLS BAD BREATH GERMS
    • WHITER SMILE** IN 7 DAYS
    • HELPS PREVENT CAVITIES
    • STRENGTHENS ENAMEL
    • FRESHENS BREATH

    ENERGIZING MINT

    IMPORTANT: Read directions for proper use.

    946 mL
    (32 FL OZ)

    97275245

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  ADVANCED W/EXTRA WHITENING
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-867
    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)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-867-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2015
    2NDC:37000-867-02946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/20/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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