Active Ingredient
Cetylpyridinium Chloride 2.30%
Double X Concentrated Mouthwash
FDA Label NDC 76670-0012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Docsmedi Co., Ltd. for the product Double X Concentrated (NDC 76670-0012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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