Label: CREST PRO-HEALTH ADVANCED ENAMEL CARE- sodium fluoride rinse

  • NDC Code(s): 69423-745-16, 69423-745-33, 69423-745-36
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

  • Purpose

    Anticavity

  • Uses

    Aids the prevention of dental cavities

  • Warnings

    Keep out of reach of children under 12 years of age.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use twice a day after brushing your teeth with toothpaste.
    • Vigorously swish 10mL (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, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, methylparaben, sucralose, poloxamer 407, propylparaben, disodium phosphate, red 33, green 3

  • Questions?

    1–800–862-7442

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati OH 45202

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    +FLUORIDE

    Crest

    PRO-HEALTH

    ADVANCED

    ANTICAVITY FLUORIDE MOUTHWASH

    ENAMEL CARE

    ALCOHOL FREE

    IMPORTANT:

    Read directions

    for proper use.

    KILLS BAD BREATH GERMS

    PROTECTS AGAINST CAVITIES

    FRESHENDS BREATH

    REBUILDS WEAKENED ENAMEL

    CLEANS THE WHOLE MOUTH

    STRENGTHENS TEETH

    1L (33.8 FL OZ)

    Label

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH ADVANCED  ENAMEL CARE
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-745
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-745-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
    2NDC:69423-745-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
    3NDC:69423-745-3636 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02202/20/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!