Label: OLIDENTAL GARGLE- 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 January 20, 2016

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  • 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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