Label: PURE MOUTH LIQUID- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 9, 2019

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  • ACTIVE INGREDIENT

    sodium fluoride

  • INACTIVE INGREDIENT

    Sodium fluoride
    Sodium saccharin
    DL-Alanine
    Citric acid
    Sodium citrate
    Xylitol
    Green extract
    Licorice extract
    Mugwort extract
    Ginger Tincture
    Sodium benzoate
    l-menthol
    Spearmint flavor
    Purified water

  • PURPOSE

    Remove bad breath, prevent tooth decay

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Use twice a day (morning and evening), use 10-15ml for one time,
    take your mouth for about 30 seconds Rinse and spit out

  • WARNINGS

    Keep the prescribed usage, capacity.
    When using in children, please use under the guidance and supervision of the guardian.
    Use only for mouthwash, do not use for internal use, guitar)
    Do not use for children under 6 years old unless directed by a pharmacist or doctor.

  • DOSAGE & ADMINISTRATION

    for oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PURE MOUTH LIQUID 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72875-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72875-0001-111 mL in 1 POUCH; Type 0: Not a Combination Product02/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/10/2019
    Labeler - On On Co., Ltd. (695015695)
    Registrant - On On Co., Ltd. (695015695)
    Establishment
    NameAddressID/FEIBusiness Operations
    On On Co., Ltd.695015695label(72875-0001) , manufacture(72875-0001)
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