Otc - Active Ingredient
Camphor 3%
Menthol 10%
Menthol, Camphor Cream
FDA Label NDC 72937-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunset Novelties, Inc for the product Menthol, Camphor (NDC 72937-310). 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, stop use and ask a doctor if, 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
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.
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 on desired area.
• Massage in circular motions until absorbed.
• Repeat as needed, but no more than 3 to 4 times per 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 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, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.
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