Label: HANIP GARGLE PINE FRAGRANCE - sodium fluoride mouthwash

  • NDC Code(s): 59303-2001-1, 59303-2001-2, 59303-2001-3
  • Packager: PISHONANC Co, Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    sodium fluoride


    Close
  • INACTIVE INGREDIENT

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


    Close
  • PURPOSE

    dental care


    Close
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


    Close
  • 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


    Close
  • WARNINGS

    keep away from heat and flame


    Close
  • DOSAGE & ADMINISTRATION

    for dental use only


    Close
  • INGREDIENTS AND APPEARANCE
    HANIP GARGLE PINE FRAGRANCE 
    sodium fluoride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59303-2001
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (FLUORIDE ION) FLUORIDE ION 20 mg  in 100000 mL
    Inactive Ingredients
    Ingredient Name Strength
    GREEN TEA LEAF  
    XYLITOL  
    GRAPEFRUIT  
    APPLE  
    PEPPERMINT  
    SODIUM BENZOATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59303-2001-3 100 in 1 PACKAGE
    1 NDC:59303-2001-2 3 in 1 PACKAGE
    1 NDC:59303-2001-1 12 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 07/13/2013
    Labeler - PISHONANC Co, Ltd (557787661)
    Registrant - PISHONANC Co, Ltd (557787661)
    Establishment
    Name Address ID/FEI Business Operations
    PISHONANC Co, Ltd 557787661 manufacture(59303-2001)
    Close