Label: COOL SENSE CARE PLUS MOUTHWASH- sodium flouride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 30, 2021

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  • ACTIVE INGREDIENT

    sodium fluoride

  • INACTIVE INGREDIENT

    Propolis extract, Turmeric extract, Xylitol, Grapefruit seed extract, Aloe extract, Matricaria extract, Rosemary extract, Green tea extract, Mulberry root extract, L-menthol, Peppermint oil, Polyoxyethylene castor oil, Poloxamer 407, Sodium benzoate, Concentrated glycerin, Steviol glycoside, Flavoring agent, Purified water

  • PURPOSE

    Helps prevent and reduce:

    Plaque formation

    Dental cavities

    Gum bleeding, soreness, and inflammation

    Halitosis

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    - Adults and children 6 years of age and older:

    Rinse for 60 secondswith 10ml (2 teaspoonful) and then spit out

    Do not swallow the rinse

    Supervise children as necessary until capable of using without supervision

    - Children under 6

    Consult a dentist or physician

  • WARNINGS

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

    Do not swallow

    If accidentally swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COOL SENSE CARE PLUS MOUTHWASH 
    sodium flouride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76670-0002-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/30/2021
    Labeler - Dr.s Medi Co.,Ltd. (694505169)
    Registrant - Dr.s Medi Co.,Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.s Medi Co.,Ltd.694505169manufacture(76670-0002)
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