FDA Label for Menthol, Camphor
View Indications, Usage & Precautions
Menthol, Camphor Product Label
The following document was submitted to the FDA by the labeler of this product Sunset Potent Pain Relief. 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
Camphor 3%
Menthol 10%
Otc - Purpose
Topical Analgesic
Use
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.
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.
Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
In case of accidental ingestion, contact doctor immediately.
If prone to allergic reaction to the product, consult to a doctor before using.
Otc - Stop Use
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
If pregnant 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 thin layer to the affected area and rub gently not more than 3 to 4 times a day.
Wash hands with soap and water after use.
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), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Cannabis Sativa (Hemp) Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Benzotriazolyl Dodecyl p-Cresol, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.
* Please review the disclaimer below.
