Double X CONCENTRATED

Manufacturer
DOCSMEDI Co., Ltd. | DONG IL PHARMS CO., LTD.
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:23

Label at a glance#

ProductDouble X CONCENTRATED
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

■ 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 2.30%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

OTHER SAFETY INFORMATION

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

Questions

OTC - QUESTIONS SECTION

■ docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2590919cetylpyridinium chloride 2.3 % Concentrated MouthwashPSN5
2590919cetylpyridinium chloride 23 MG/ML MouthwashSCD5
2590919cetylpyridinium chloride 2.296 % MouthwashSY5
2590919cetylpyridinium chloride 2.3 % MouthwashSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76670-0012-1Double X CONCENTRATED30 mL in 1 CONTAINERMOUTHWASH305
76670-0012-2Double X CONCENTRATED2 in 1 CARTONMOUTHWASH25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76670-0012DOUBLE X CONCENTRATED (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [DOCSMEDI CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20250123_411be334-364c-4074-8d0b-8dda332f87de.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76670-001276670-0012-1, 76670-0012-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Double X CONCENTRATEDCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.411be334-364c-4074-8d0b-8dda332f87de2025-01-22WarningsExact identifier
ndc (package): 76670-0012-1
ndc (package): 76670-0012-2
ndc (product): 76670-0012
ndc11 (package): 76670001202
ndc11 (package): 76670001201
spl id: 2c487d0a-fb67-49ad-e063-6294a90a939b
spl set id: 411be334-364c-4074-8d0b-8dda332f87de

Reported adverse events (FAERS/openFDA)#

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