COOL SENSE CARE PLUS MOUTHWASH- sodium flouride liquid

Cool Sense Care Plus Mouthwash by

Drug Labeling and Warnings

Cool Sense Care Plus Mouthwash by is a Otc medication manufactured, distributed, or labeled by Dr.s Medi Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

COOL SENSE CARE PLUS MOUTHWASH 
sodium flouride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76670-0002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76670-0002-1	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/30/2021

Labeler - Dr.s Medi Co.,Ltd. (694505169)

Registrant - Dr.s Medi Co.,Ltd. (694505169)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.s Medi Co.,Ltd.		694505169	manufacture(76670-0002)