Analgesic
Analgesic is an FDA drug label for the active ingredient MENTHOL manufactured by Safetec of America, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20181001.
Generic: MENTHOL
Manufacturer: Safetec of America, Inc.
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 61010-8202
Application: part348
Effective: 20181001
Active Ingredients: Active Ingredients USP Menthol 7%
Indications & Usage
Uses Temporary relief of minor aches and pains of muscles and joints.
Dosage & Administration
Directions For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.
Contraindications
Not available.
Warnings
Warnings For external use only. Flammable. Keep away from flame. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.
Adverse Reactions
Not available.
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