COOL SENSE CARE PLUS MOUTHWASH- sodium flouride liquid 
Dr.s Medi Co.,Ltd.

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.

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Drug Facts

sodium fluoride

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

Helps prevent and reduce:

Plaque formation

Dental cavities

Gum bleeding, soreness, and inflammation

Halitosis

KEEP OUT OF REACH OF THE CHILDREN

- 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

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.

dental use only

label

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)

Revised: 7/2021
Document Id: c8541a8c-23a5-86b8-e053-2995a90a21bb
Set id: c8529d7a-f93c-9bba-e053-2995a90a9fea
Version: 2
Effective Time: 20210730
 
Dr.s Medi Co.,Ltd.