DR.PIK ORAL CARE GARGLE (SODIUM FLUORIDE) LIQUID [DR.PIK CO.,LTD]

DR.PIK ORAL CARE GARGLE (SODIUM FLUORIDE) LIQUID [DR.PIK CO.,LTD]
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NDC 72857-010-01
Set ID 6f82ab54-2f53-499f-8678-88998f36626b
Category HUMAN OTC DRUG LABEL
Packager Dr.pik Co.,ltd
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT

    Active ingredients: Sodium fluoride 0.05%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Alcohol, Xyitol, Flavor (apple spearmint), L-Menthol, Acetic acid, Sodium benzoate, Sodium citrate, Citric acid, Stevioside, Sodium saccharin

  • PURPOSE

    Purpose: Anticaries

  • WARNINGS

    Warnings:
    1) Keep the prescribed usage, capacity. 2) When using to children, please use under the guidance and supervision of the guardian. 3) Since this product is high in concentration, be sure to add it to the water supply tank of the Dr.pik’s 'Vacuum Oral Care'. 4) Use only for oral cleaning. Do not use besides the intended use. If large quantities have been swallowed, consult a physician immediately. 5) Children under 6 years old, please do not use without instructions from a pharmacist or doctor. 6) Please keep out of reach of children. 7) Avoid direct sunlight, keep as cool as possible. 8) Please do not put in another container for quality preservation.

  • KEEP OUT OF REACH OF CHILDREN

    Please keep out of reach of children.

  • Uses

    Uses:
    Helps prevent dental caries and remove bad breath.

  • Directions

    Directions:
    Add 15ml of Dr.pik Oral Care Gargle measured by the cap to the supply tank of Vacuum Oral Care.
    After filling water up to the line of the supply tank, add Dr.pik Oral Care Gargle.
    Do not use the solution without diluting for gargling purpose.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    DR.PIK ORAL CARE GARGLE 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72857-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72857-010-01300 mL in 1 CONTAINER; Type 0: Not a Combination Product01/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/02/2019
    Labeler - Dr.pik Co.,ltd (694609614)
    Registrant - Dr.pik Co.,ltd (694609614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecoworld Co .,ltd688735061manufacture(72857-010)

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