Label: COLGATE ENAMEL STRENGTH MOUTHWASH- sodium fluoride rinse

  • NDC Code(s): 35000-734-98
  • Packager: Colgate-Palmolive - do not use
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 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

  • 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 of age and 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

  • Other information

    Store at controlled room temperature 68 – 77° F (20 – 25°C)

  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Cetylpyridinium Chloride, Disodium Phosphate, Potassium Sorbate, Sucralose, Green 3

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE CO.
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    ALCOHOL FREE

    Colgate®
    Anticavity Fluoride Mouthwash

    ENAMEL
    STRENGTH®

    ANTICAVITY PROTECTION
    WITH FLUORIDE FOR STRONGER TEETH

    Strengthens Enamel

    Helps Prevent Cavities

    Helps replenish natural calcium
    back into enamel

    10X LONGER LASTING COOL**

    SPARKLING FRESH MINT

    P9932531

    16.9 FL OZ (1.05 PT) 500 mL

    IMPORTANT:
    Read directions
    for proper use

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE ENAMEL STRENGTH MOUTHWASH 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-734
    Route of AdministrationDENTAL
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-734-98500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02110/03/2019
    Labeler - Colgate-Palmolive - do not use (001344381)
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!