Label: DOUBLE X CONCENTRATED- cetylpyridinium chloride mouthwash

  • NDC Code(s): 76670-0012-1, 76670-0012-2
  • Packager: DOCSMEDI OralBiome Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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

  • ACTIVE INGREDIENT

    Cetylpyridinium Chloride 2.30%

  • INACTIVE INGREDIENTS

    Chitosan, Propolis extract, Turmeric root extract, D-sorbitol solution, Grapefruit seed extract, Peppermint flavor Xylitol, Enzymatically modified stevia, Taraxacum platycarpum extract, Green tea extract, Gardenia Blue, Purified water

  • PURPOSE

    Antigingivitis, Antiplaque

  • WARNINGS

    Keep out of reach of children under 6 years of age.
    ■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
    Stop use and ask a dentist if
    ■ gingivitis, bleeding or redness persists for more than 2 weeks
    ■ you have painful or swollen gum, pus from the gumline, loose teeth, or increasing spacing between the teeth. Theses may be signs or symptoms of periodontitis, a serious form of gum disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.
    ■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    ■ Helps prevent and reduce plaque and gingivitis
    ■ Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

  • Directions

    ■ Add a 5 drops of this solution to the enclosed cup, add water to the marked line (20ml).
    ■ Adults and children 12 years of age and older: vigorously 1/2 oz. (20ml) of rinse, twice a day, for 30seconds and then spit out.
    ■ Children 6 years to under 12 years: supervise use.
    ■ Children under 6 years of age: do not use

  • Other Information

    ■ Airtight container, Store in normal temperature 1~30°C (34~86°F)

  • 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
    DOUBLE X CONCENTRATED 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) Cetylpyridinium Chloride2.30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    TURMERIC (UNII: 856YO1Z64F)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76670-0012-22 in 1 CARTON01/02/2022
    1NDC:76670-0012-130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/02/2022
    Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(76670-0012)