Label: COOL SENSE STICK GARGLE- cetylpyridinium chloride liquid

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

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Drug Label Information

Updated January 22, 2025

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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

    ■ Stop using this product and consult a dentist if irritation or discomfort occurs.

    ■ For children under 6 years of age, use only a small amount of toothpaste under adult supervision to prevent sucking or swallowing.

    ■ If a child under 6 swallows a large amount of toothpaste, seek immediate medical attention or consult a dentist.

    ■ Keep this product out of the reach of children under 6 years of age

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    ■ Aids in prevention of dental 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: 82-031-365-4596

  • PRINCIPAL DISPLAY PANEL

    Carton Image

  • 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 Co., Ltd. (694505169)
    Registrant - DOCSMEDI Co., Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(76670-0015)
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