Otc - Active Ingredient
Active ingredient(s)
Cetylpyridinium Chloride 2.296%
Cool Sense Concentrated Mouthwash
FDA Label NDC 73242-1125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dong Il Pharms Co.,ltd for the product Cool Sense Concentrated (NDC 73242-1125). 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 otc - active ingredient, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients
Water, D-Sorbitol Solution, Peppermint Flavor , Propolis Extract, Gardenia Blue Color, Chitosan, Xylitol, Grapefruit Seed Extract, Enzymatically Modified Stevia, Lactic Acid Bacteria Fermented Solution, Green Tea Extract, Curcuma Longa (Turmeric) Root Extract, Taraxacum Officinale Extract
Otc - Purpose
Purpose
Antigingivitis / Antiplaque
Warnings
Warnings
■ Do not store above 30°C (86°F).
■ Keep away from heat, sparks, and open flames.
■ Avoid contact with eyes, as this product may cause irritation.
■ If eye contact occurs, rinse thoroughly with water.
■ Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
Use(s)
■ Helps remove plaque
■ Helps cleanse and freshen the mouth
■ Helps reduce oral malodor (bad breath)
■ Helps maintain oral cleanliness
Dosage & Administration
Directions
■ Use three times daily.
■ Place 5 drops of the concentrated solution into the provided cup.
■ Add water up to the indicated line to dilute.
■ Rinse (gargle) with the diluted solution for about 30 seconds, then spit out.
■ Do not swallow.
Other Safety Information
Other Information
■ Airtight container, Store in room temperature (1~30℃)
Otc - Questions
Questions
■ Tel: +82) 31-922-2240, Fax: 82-031-365-4596
■ Fax: +82) 31-365-4596
■ Web: docsmedi.co.kr
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