Cool Sense Care Plus Mouthwash

Manufacturer: Dr.s Medi Co.,Ltd.
Effective date: 2021-07-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:41:43

Label at a glance#

ProductCool Sense Care Plus Mouthwash

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Helps prevent and reduce:

Plaque formation

Dental cavities

Gum bleeding, soreness, and inflammation

Halitosis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

- 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 SECTION

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 SECTION

dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	2
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	2
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	2
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76670-0002-1	2022-07-29	C162847	48780-1	e4f33bdf-ad82-d8a0-e053-dadaa90a6e4e	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76670-0002-1	Cool Sense Care Plus Mouthwash	250 mL in 1 BOTTLE	LIQUID	250		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76670-0002	COOL SENSE CARE PLUS MOUTHWASH (SODIUM FLOURIDE) LIQUID [DR.S MEDI CO.,LTD.]	2	Legacy NDC, 1 package rows	20210731_c8529d7a-f93c-9bba-e053-2995a90a9fea.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Cool Sense Care Plus Mouthwash
Sodium Flouride
WATER
SODIUM FLUORIDE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76670-0002	76670-0002-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c8541a8c-23a5-86b8-e053-2995a90a21bb			c8529d7a-f93c-9bba-e053-2995a90a9fea	2021-07-30	Warnings	Exact identifier spl id: c8541a8c-23a5-86b8-e053-2995a90a21bb spl set id: c8529d7a-f93c-9bba-e053-2995a90a9fea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.