COOL SENSE STICK GARGLE- cetylpyridinium chloride liquid 
DOCSMEDI OralBiome Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

Image of carton
COOL SENSE STICK GARGLE 
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0015
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) Cetylpyridinium Chloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Sodium benzoate (UNII: OJ245FE5EU)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76670-0015-230 in 1 CARTON02/01/2023
1NDC:76670-0015-110 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2023
Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)
Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(76670-0015)

Revised: 12/2023
Document Id: f26cffd8-9a76-43d8-8fe0-5a3a3f5792f2
Set id: 4d1fca5a-d01d-4362-abd8-ffdff1275bfd
Version: 2
Effective Time: 20231205
 
DOCSMEDI OralBiome Co., Ltd.