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Drug Facts
Listerine Cool Mint Antiseptic Liquid
FDA Label NDC 67751-216
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Listerine Cool Mint Antiseptic (NDC 67751-216). 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 other, active ingredients, purposes, uses, warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Thymol 0.064%
Purposes
Antiplaque/antigingivitis
Uses
Helps prevent and reduce:
- Plaque
- Gingivitis
Otc - Do Not Use
Do not use in children under 12 years of age
Otc - Ask Doctor
Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
- do not swallow
Other Information
- this rinse is not intended to replace brushing or flossing.
- store at room temperature
- cold weather may cloud this product. Its antiseptic properties are not affected.
Inactive Ingredients
Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3
Questions Or Comments?
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