FDA Label for Cool Relief Oral Anesthetic
View Indications, Usage & Precautions
Cool Relief Oral Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Ricola Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Purpose
Oral anesthetic
Active Ingredient (In Each Drop)
Menthol, 13.2 mg
Uses
temporarily relieves occasional minor irritation and pain associated with
- sore mouth
- sore throat
Warnings
Do not use
- in children under 5 years of age unless directed by a doctor
- 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.
Sore throat warnings:
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
extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar
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