COOL SENSE STICK GARGLE- cetylpyridinium chloride liquid

COOL SENSE STICK GARGLE by

Drug Labeling and Warnings

COOL SENSE STICK GARGLE 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

Cetylpyridinium Chloride 0.05%

Inactive ingredients

Sodium benzoate, Concentrated Glycerin, Disodium EDTA, Polyoxyethylene hydrogenated caster oil, Citric acid, Trisodium Citrate dehydrate, Xylitol, Enzymatically Modified Stevia, Rosemary extract, Calendula flower extract, Aloe extract(09), Salvia (Sage) extract, Eucalyptus Globulus Leaf extract, L-menthol, Peppermint Oil, Lemon 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

■ Helps protect against cavities

Directions

■ Rinse mouth with this COOLSENSE STICK GARGLE 10ml 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 STICK GARGLE 
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76670-0015
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium benzoate (UNII: OJ245FE5EU)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76670-0015-2	30 in 1 CARTON	02/01/2023
1	NDC: 76670-0015-1	10 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2023

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(76670-0015)