FDA Label for Menthol
View Indications, Usage & Precautions
Menthol Product Label
The following document was submitted to the FDA by the labeler of this product Sunset Pain Relief Roll-on 3oz. 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.
Otc - Active Ingredient
Menthol 4%
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, Glycerin, Ceteareth-25, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Cannabidiol, Methyl Salicylate.
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