Label: MASTIC DENT- sodium fluoride, eucalyptol, thymol and menthol mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 20, 2012

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

View All Sections
  • Active Ingredients

    Drug Facts:

    Active Ingredients:

    • Sodium Fluoride 0.025% - Anticavity
    • Eucalyptol 0.092%, Menthol 0.042% - Antigingivitis , Antiplaque
    • Thymol 0.064% - Antigingivitis, Antiplaque

  • Warnings

    Warning:

    • Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.
    • Stop use and ask dentist if gingivitis, bleeding, or redness persists more than 2 weeks.

  • Keep out of reach.

    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

    Directions:

    • Adults and children 12 of age and older - Vigorously swish 20mL (2.3 Fl. Oz or 4 tea-spoonfuls) between teeth for 30 seconds then spit out, do not swallow.
    • Children under 12 years of age - Consult a dentist or doctor
    • This rinse is not intended to replace brushing or flossing.
  • Other information

    Other Information:

    • Cold weather may cloud this product. Its anticeptic properties are not affected. Store at room temperature (25 C - 77 F).
  • Inactive Ingredients

    Inactive Ingredients:

    AQUA, Alcohol Denaturated, Sorbitol, Sodium Lauroyl Sarcosinate, Sodium Phosphate, Peg-40 Hydrogenated Castor Oil, Sodium Benzoate, Fragrance, Disodium EDTA, Sodium Saccharin, Pistacia Lentiscus Mastic Gum, Pistacia Lentiscus Seed Oil, Acid Blue 9 CI 42090

  • Information of owner

    Product Of Chios

    CHIA GI LTD

    144 AG. MINA, HIOS, 82100

    GREECE
    Tel.: 30-22710-33101, FAX: 30-22710-32229
    www.masticspa.com
    Made In Greece
  • PURPOSE SECTION

    Reduces Gingivitis

  • Dosage

    Dosage - Vigorously swish 20mL (2/3 Fl. OZ or 4 team - spoonfuls) between teeth for 30 seconds, then spit out do not swallow.

  • ImageofMouthwash.jpg

    ImageofMouthwash.jpg

  • INGREDIENTS AND APPEARANCE
    MASTIC DENT 
    sodium fluoride, eucalyptol, thymol and menthol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15304-4085
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.25 mg  in 1 mL
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    PISTACIA LENTISCUS SEED OIL (UNII: Z7D029774C)  
    PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALCOHOL (UNII: 3K9958V90M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (Acid Blue 9 (CI 42090)) Score    
    ShapeSize
    FlavorMINT (Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15304-4085-1400 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/22/2005
    Labeler - Chia Gi LTD (363215270)
    Registrant - Chia Gi LTD (363215270)
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!