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 Novelties, Inc. 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.
Dosage & Administration
Adults and children over 12 years of age; apply a thin layer to 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 unless directed by doctor/physician
Warnings
For external use only.
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.
Inactive Ingredient
Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue #1 Powder (CI 42090).
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.
Otc - Keep Out Of Reach Of Children
Keep away from children. Package not child resistant.
Otc - Purpose
External Analgesic
Pain Relieving
Otc - Active Ingredient
Menthol 10%
Camphor 3%
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