Label: COOL SENSE STICK GARGLE- cetylpyridinium chloride liquid

  • NDC Code(s): 76670-0015-1, 76670-0015-2
  • Packager: DOCSMEDI OralBiome Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 5, 2023

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  • ACTIVE INGREDIENT

    Cetylpyridinium Chloride 0.05%

  • Inactive ingredients

    Sodium benzoate, Concentrated Glycerin, Disodium EDTA, Polyoxyethylene hydrogenated caster oil, Citric acid, Trisodium Citrate dehydrate, Xylitol, Enzymatically Modified Stevia, Rosemary extract, Calendula flower extract, Aloe extract(09), Salvia (Sage) extract, Eucalyptus Globulus Leaf extract, L-menthol, Peppermint Oil, Lemon 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

    ■ Helps protect against cavities

  • Directions

    ■ Rinse mouth with this COOLSENSE STICK GARGLE 10ml 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 carton
  • INGREDIENTS AND APPEARANCE
    COOL SENSE STICK GARGLE 
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0015
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) Cetylpyridinium Chloride0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium benzoate (UNII: OJ245FE5EU)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76670-0015-230 in 1 CARTON02/01/2023
    1NDC:76670-0015-110 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2023
    Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(76670-0015)
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