Drug Facts
Purpose
Oral anesthetic
Cool Relief Lemon Frost Oral Anesthetic Lozenge
FDA Label NDC 63667-156
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ricola Usa Inc. for the product Cool Relief Lemon Frost Oral Anesthetic (NDC 63667-156). 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 drug facts, active ingredient (in each drop), uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Drop)
Menthol, 16.0 mg
Uses
temporarily relieves occasional minor irritation and pain associated with:
- sore mouth
- sore throat
Warnings
Sore throat warnings:
- if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.
Keep Out Of Reach Of Children.
Directions
- adults and children 6 years and older: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
- children under 6 years: ask a doctor
- do not bite or chew
Other Information
protect from heat and moisture
Inactive Ingredients
citric acid, colors (carrot), extract of bee balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), honey, lemon juice concentrate, starch syrup, sugar
Package Label.Principal Display Panel
Cool_relief_lemon_ricola19ctfinal.jpg (Cool Relief Lemon Ricola19ctfinal)
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