Label: COOL SENSE CARE PLUS- sodium fluoride mouthwash

  • NDC Code(s): 76670-0013-1
  • Packager: DOCSMEDI OralBiome Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • ACTIVE INGREDIENT

    Sodium fluoride 0.05%
    (Total Fluoride Content 277 ppm Approx.)

  • Inactive ingredients

    Sodium benzoate, Propolis extract, Turmeric root extract, Xylitol, GrapefruitSeed extract, Aloe extract(09), Matricaria extract, rosemary extract, Green tea extract, Mulberry Root extract, Peppermint oil, L-menthol, Naturalaromatics, Steviol glycoside, Concentrated glycerin, Polyoxyethylene hydrogenated caster oil, Poloxamer 407, Purified water

  • PURPOSE

    Anticavity mouthwash

  • WARNINGS

    ■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if
    ■ For children under 6 years of age, use small amounts under the supervision of a guardian to avoid sucking or swallowing.
    ■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
    ■ Keep out of the reach of children under 6 years of age.

  • KEEP OUT OF REACH OF CHILDREN

    ■ Keep out of the reach of children under 6 years of age.

  • Uses

    ■ Aids in prevention of dental cavities

  • Directions

    ■ Rinse mouth with this COOLSENSE CARE PLUS about 10~15ml for 60 seconds then expel

  • Other Information

    ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

  • Questions

    ■ https://docsmedi.kr
    ■ Tel: 82-031-922-2240, Fax: 82-43-883-2844

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle
  • INGREDIENTS AND APPEARANCE
    COOL SENSE CARE PLUS 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0013
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium benzoate (UNII: OJ245FE5EU)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76670-0013-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/01/2022
    Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(76670-0013)
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