OLIDENTAL GARGLE (SODIUM FLUORIDE) LIQUID [AJU PHARM CO., LTD.]

OLIDENTAL GARGLE (SODIUM FLUORIDE) LIQUID [AJU PHARM CO., LTD.]
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NDC 70417-001-01
Set ID 71f907b8-8f28-4fd2-a035-b79cbf9ab860
Category HUMAN OTC DRUG LABEL
Packager AJU PHARM CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT

    Sodium Fluoride 0.02%

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE

    Aids in the prevention of dental cavities

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:
    • Use twice daily after brushing your teeth with a toothpaste
    • Vigorously swish 10mL (2 teaspoonfuls) of rinse 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
    • Supervise children as necessary until capable of suing without supervisor

    Children under 12 years of age: consult a dentist or doctor

  • WARNINGS

    Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

  • KEEP OUT OF REACH OF CHILDREN

    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

  • INACTIVE INGREDIENT

    Glycerin, Allantoin, Xylitol, Stevioside, Acetic acid, Sodium bicarbonate, Sodium acetate, Olive leaf extract, Sodium Benzoate, Green Tea Extract, Sodium Saccharin, L-Menthol, Citrus flavoring, Lemon flavoring, Propolis Extract, Lemon Oil, Cacao Color, Purified water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    OLIDENTAL GARGLE 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70417-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.06 mg  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    LEMON OIL (UNII: I9GRO824LL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70417-001-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/20/2016
    Labeler - AJU PHARM CO., LTD. (687982405)
    Registrant - AJU PHARM CO., LTD. (687982405)
    Establishment
    NameAddressID/FEIBusiness Operations
    AJU PHARM CO., LTD.687982405manufacture(70417-001)

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