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| Product NDC Code | 76670-0012 | ||||
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| Drug Name | Double x concentrated |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 2590919 | ||||
| Application Number | M021 | ||||
| Labeler Name | DOCSMEDI OralBiome Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Cetylpyridinium Chloride 2.30%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ Helps prevent and reduce plaque and gingivitis ■ Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
Purpose
Information about the drug product’s indications for use.PURPOSE Antigingivitis, Antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Double X CONCENTRATED Cetylpyridinium Chloride Cetylpyridinium Chloride CETYLPYRIDINIUM PROPOLIS WAX TURMERIC SORBITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Airtight container, Store in normal temperature 1~30°C (34~86°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions https://docsmedi.kr Tel: 82-031-922-2240, Fax: 82-43-883-2844
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API