Otc - Active Ingredient
Menthol 4%
Menthol Gel
FDA Label NDC 49283-577
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chemco Corporatiom for the product Menthol (NDC 49283-577). 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, otc - purpose, use, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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
Otc - Purpose
Topical Analgesic
Use
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only. · Ask a doctor before use if you have redness over affected area
Otc - When Using
Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken or irritated skin.
If you experience an allergic reaction, discontinue use and consult a doctor.
Do not expose the area treated with product to heat or direct sunlight.
Otc - Stop Use
Stop use and ask a doctor if
Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.
You experience signs injury, such as pain, swelling or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison Control Center right away.
Directions
Adults and Children over 12 years
Apply a small amount to the affected area.
Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Children under 12 years of age: do not use, consult a doctor.
Other Safety Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Inactive Ingredient
Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Carbomer, Sodium Hydroxide, Cannabis Sativa Seed Oil, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid.
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