Otc - Active Ingredient
sodium fluoride
Cool Sense Care Plus Mouthwash
FDA Label NDC 76670-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr.s Medi Co.,ltd. for the product Cool Sense Care Plus Mouthwash (NDC 76670-0002). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Propolis extract, Turmeric extract, Xylitol, Grapefruit seed extract, Aloe extract, Matricaria extract, Rosemary extract, Green tea extract, Mulberry root extract, L-menthol, Peppermint oil, Polyoxyethylene castor oil, Poloxamer 407, Sodium benzoate, Concentrated glycerin, Steviol glycoside, Flavoring agent, Purified water
Otc - Purpose
Helps prevent and reduce:
Plaque formation
Dental cavities
Gum bleeding, soreness, and inflammation
Halitosis
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF THE CHILDREN
Indications & Usage
- Adults and children 6 years of age and older:
Rinse for 60 secondswith 10ml (2 teaspoonful) and then spit out
Do not swallow the rinse
Supervise children as necessary until capable of using without supervision
- Children under 6
Consult a dentist or physician
Warnings
Keep out of reach of children under 6 years of age.
Do not swallow
If accidentally swallowed, get medical help or contact Poison Control Center right away.
Dosage & Administration
dental use only
Package Label.Principal Display Panel
Label (Label)
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