Label: WHITENING FOAMING- sodium fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 17, 2010

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

View All Sections
  • ACTIVE INGREDIENT

    active ingredients: sodium fluoride, allantoin
  • INACTIVE INGREDIENT

    inactive ingredients: ethanol sodium lauryl sulfact, xylitol, sodium saccharin, ginger, mugwort extract, cnidium extract, mint, methylparaben, water
  • PURPOSE

    for dental care
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    brush teeth with your tooth brush or gargle after spraying it into your mouth
  • WARNINGS

    store at room temperature
  • DOSAGE & ADMINISTRATION

    use when needed
    dental use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    WHITENING FOAMING 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.001 mL  in 1 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0005 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHANOLAMINE (UNII: 5KV86114PT)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GINGER (UNII: C5529G5JPQ)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
    MINT (UNII: FV98Z8GITP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75902-1001-150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/17/2010
    Labeler - Dio Corporation (631085206)
    Registrant - Dio Corporation (631085206)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dio Corporation631085206manufacture
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!