Label: THERASTOM- antigingivitis/antiplaque mouth rinse rinse

  • NDC Code(s): 70275-936-16
  • Packager: Forward Science Technologies LLC
  • 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 January 10, 2023

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  • Inactive Ingredients

    Calcium Disodium EDTA, Flavor (Peppermint, Eucalyptus, Pink Grapefruit), Glycerin, PEG-40, Propylene Glycol, Water, Xylitol, Zinc Gluconate

  • Active Ingredient

    Cetylpyridinium Chloride 0.075%

  • Purpose

    Antigingivitis/Antiplaque

  • Use(s)

    • Helps control plaque that leads to bleeding gums.
    • Helps prevent gingivitis, an early form of gum disease .

  • Warnings

    Stop use and ask a dentist if:
    • Gingivitis, bleeding, or redness persists for more than 2 weeks
    • You have painful or swollen gums, pus from the gum line, loose teeth, or increased spacing between the teeth.
    These may be signs or symptoms of periodontitis, a serious form of gum disease.

  • Keep out of reach of children

    Keep out of reach of children under 6 years of age.
    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years or older: Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
    • Children 6 years to under 12 years of age: supervise use
    • Children under 6 years of age: do not use

  • Other information

    This rinse is not intended to replace brushing or flossing

  • Dosage

    Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out.

  • PRINCIPAL DISPLAY PANEL

    therastombottlelabel

  • INGREDIENTS AND APPEARANCE
    THERASTOM 
    antigingivitis/antiplaque mouth rinse rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70275-936
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.075 mg  in 0.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70275-936-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/05/2021
    Labeler - Forward Science Technologies LLC (079212068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Forward Science Technologies LLC079212068manufacture(70275-936)
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