DOUBLE X CONCENTRATED- cetylpyridinium chloride mouthwash

Double X CONCENTRATED by

Drug Labeling and Warnings

Double X CONCENTRATED by is a Otc medication manufactured, distributed, or labeled by Dr.s Medi Co.,Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetylpyridinium Chloride 2.30%

INACTIVE INGREDIENTS

Chitosan, Propolis extract, Turmeric root extract, D-sorbitol solution, Grapefruit seed extract, Peppermint flavor Xylitol, Enzymatically modified stevia, Taraxacum platycarpum extract, Green tea extract, Gardenia Blue, Purified water

PURPOSE

Antigingivitis, Antiplaque

WARNINGS

Keep out of reach of children under 6 years of age.
■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a dentist if
■ gingivitis, bleeding or redness persists for more than 2 weeks
■ you have painful or swollen gum, pus from the gumline, loose teeth, or increasing spacing between the teeth. Theses may be signs or symptoms of periodontitis, a serious form of gum disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.
■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Uses

■ Helps prevent and reduce plaque and gingivitis
■ Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Directions

■ Add a 5 drops of this solution to the enclosed cup, add water to the marked line (20ml).
■ Adults and children 12 years of age and older: vigorously 1/2 oz. (20ml) of rinse, twice a day, for 30seconds and then spit out.
■ Children 6 years to under 12 years: supervise use.
■ Children under 6 years of age: do not use

Other Information

■ Airtight container, Store in normal temperature 1~30°C (34~86°F)

Questions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOUBLE X CONCENTRATED 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76670-0012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	2.30 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
TURMERIC (UNII: 856YO1Z64F)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76670-0012-2	2 in 1 CARTON	01/02/2022
1	NDC: 76670-0012-1	30 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
OTC Monograph Drug	M021	01/02/2022

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(76670-0012)