Label: TRUWELL DENTIWASH- sodium fluoride liquid

  • NDC Code(s): 61284-0013-1, 61284-0013-2
  • Packager: ECOWORLDPHARM CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 4, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    sodium fluoride

  • INACTIVE INGREDIENT

    purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan

  • PURPOSE

    aids in the prevention of dental cavities

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Adults and children 6 years of age and older:

    use twoce a day after brishing your teeth with a toothpaste

    vigorously swish contents of one (1) 11mL packet 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 uder 6 years of age: consult a dentist or doctor

  • WARNINGS

    if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    for dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TRUWELL DENTIWASH 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61284-0013
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    MALIC ACID (UNII: 817L1N4CKP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61284-0013-2250 in 1 PACKAGE10/05/2023
    1NDC:61284-0013-111 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02110/05/2023
    Labeler - ECOWORLDPHARM CO.,LTD (688735061)
    Registrant - ECOWORLDPHARM CO.,LTD (688735061)
    Establishment
    NameAddressID/FEIBusiness Operations
    ECOWORLDPHARM CO.,LTD688735061manufacture(61284-0013)
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!