COOL SENSE CARE PLUS- sodium fluoride mouthwash

Cool sense Care Plus by

Drug Labeling and Warnings

Cool sense Care Plus by is a Otc medication manufactured, distributed, or labeled by DOCSMEDI OralBiome Co., Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium fluoride 0.05%
(Total Fluoride Content 277 ppm Approx.)

Inactive ingredients

Sodium benzoate, Propolis extract, Turmeric root extract, Xylitol, GrapefruitSeed extract, Aloe extract(09), Matricaria extract, rosemary extract, Green tea extract, Mulberry Root extract, Peppermint oil, L-menthol, Naturalaromatics, Steviol glycoside, Concentrated glycerin, Polyoxyethylene hydrogenated caster oil, Poloxamer 407, Purified water

PURPOSE

Anticavity mouthwash

WARNINGS

■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if
■ For children under 6 years of age, use small amounts under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
■ Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

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

Uses

■ Aids in prevention of dental cavities

Directions

■ Rinse mouth with this COOLSENSE CARE PLUS about 10~15ml for 60 seconds then expel

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

■ https://docsmedi.kr
■ Tel: 82-031-922-2240, Fax: 82-43-883-2844

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL SENSE CARE PLUS 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76670-0013
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium benzoate (UNII: OJ245FE5EU)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76670-0013-1	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/01/2022

Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)

Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(76670-0013)