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

  • NDC Code(s): 37000-865-01, 37000-865-02, 37000-865-36
  • 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 September 4, 2019

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

  • 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, red 33, green 3

  • Questions?

    1-800-285-9139

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    865 labels.jpgALCOHOL 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:37000-865
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-865-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2016
    2NDC:37000-865-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2016
    3NDC:37000-865-3636 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 finalpart35507/20/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufacturing Company (Iowa City)005279245manufacture(37000-865)