Label: CREST PRO-HEALTH RESTORE ENAMEL- sodium fluoride rinse

  • NDC Code(s): 69423-909-01
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 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 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, propylene glycol, poloxamer 407, polysorbate 80, flavor, benzoic acid, sucralose, sodium benzoate, phosphoric acid, disodium phosphate, blue 1, yellow 5

  • Questions?

    1–800–285–9139

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

    ALCOHOL FREE

    +FLUORIDE

    Crest ®

    PRO-HEALTH™

    ANTICAVITY FLUORIDE RINSE

    RESTORES WEAKENED ENAMEL

    IMPORTANT: Read directions for proper use.

    Protects Against Cavities

    Strengthens Teeth

    Freshens Breath

    CLEAN MINT

    1L (33.8 FL OZ)

    69423909

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  RESTORE ENAMEL
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-909
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-909-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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