Label: HANIP GARGLE APPLE FRAGRANCE- sodium fluoride mouthwash

  • 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 July 13, 2013

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  • ACTIVE INGREDIENT

    sodium fluoride


  • INACTIVE INGREDIENT

    green tea extract, xylitol, grape fruit extract, apple fragrance, peppermint fragrance, sodium beozoate


  • PURPOSE

    dental care


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    - gargle a cap for about 60 seconds and then spit out
    - in case of children under 6 years of age, use 1/2 cap and care for not swallowing
    - before meeting, for old man or patient used easily


  • WARNINGS

    keep away from heat and flame


  • DOSAGE & ADMINISTRATION

    for dental use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    HANIP GARGLE APPLE FRAGRANCE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59303-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 100000 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    APPLE (UNII: B423VGH5S9)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59303-1001-3100 in 1 PACKAGE
    1NDC:59303-1001-23 in 1 PACKAGE
    1NDC:59303-1001-112 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/13/2013
    Labeler - PISHONANC Co, Ltd (557787661)
    Registrant - PISHONANC Co, Ltd (557787661)
    Establishment
    NameAddressID/FEIBusiness Operations
    PISHONANC Co, Ltd557787661manufacture(59303-1001)
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