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| Product NDC Code | 76670-0013 | ||||
|---|---|---|---|---|---|
| Drug Name | Cool sense care plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 240698 | ||||
| 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 Sodium fluoride 0.05% (Total Fluoride Content 277 ppm Approx.)
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 ■ Rinse mouth with this COOLSENSE CARE PLUS about 10~15ml for 60 seconds then expel
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sodium benzoate, Propolis extract, Turmeric root extract, Xylitol, GrapefruitSeed extract, Aloe extract(09), Matricaria extract, rosemary extract, Green tea extract, Mulberry Root extract, Peppermint oil, L-menthol, Naturalaromatics, Steviol glycoside, Concentrated glycerin, Polyoxyethylene hydrogenated caster oil, Poloxamer 407, 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 ■ Aids in prevention of dental cavities
Purpose
Information about the drug product’s indications for use.PURPOSE Anticavity mouthwash
Spl product data elements
Usually a list of ingredients in a drug product.Cool sense Care Plus Sodium fluoride Sodium fluoride FLUORIDE ION Sodium benzoate PROPOLIS WAX
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 bottle
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 the reach of children under 6 years of age.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
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 ■ 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.
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