Label: GO SMILE RELAX- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 44873-007-00, 44873-007-01
  • Packager: Go Smile, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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

View All Sections
  • PURPOSE

    ANTICAVITY

  • KEEP OUT OF REACH OF CHILDREN

    WARNINGS: KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

  • DIRECTIONS

    • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS.
    • INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION.
    • CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.
  • INACTIVE INGREDIENTS

    SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT.

  • PURPOSE

    ANTICAVITY

  • ACTIVE INGREDIENTS

    ​SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE ION)

  • WARNINGS

    IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • PRINCIPAL DISPLAY PANEL

    GO SMiLE PM 1.0 ozTube_V5_7_11

    GO SMiLE PM 3.5 ozTube_V4_7_11

  • INGREDIENTS AND APPEARANCE
    GO SMILE  RELAX
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    VALERIAN (UNII: JWF5YAW3QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44873-007-00100 g in 1 TUBE; Type 0: Not a Combination Product05/05/2011
    2NDC:44873-007-0128 g in 1 TUBE; Type 0: Not a Combination Product05/05/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/05/2011
    Labeler - Go Smile, Inc. (139729631)
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!