Otc - Active Ingredient
Menthol 10%
Camphor 3%
Menthol, Camphor Cream
FDA Label NDC 49283-576
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 Corporation for the product Menthol, Camphor (NDC 49283-576). 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, uses, warnings, otc - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Pain Relieving
Uses
For the temporary relief of minor aches and pains of muscles and joints associated
with simple backache, arthritis, sprains and strains.
Warnings
Use only as directed. For external use only. Do not bandage tightly. Do not use with heating pad,
pack, wrap, hot water bottle or any heating element. Keep away from children. Package not child
resistant. In case of accidental ingestion, contact doctor immediately. If prone to allergic reaction to
the product, consult to a doctor before using.
Otc - When Using
Avoid contact with eyes, mucous membranes, rashes, wounds or damaged skin. Do not apply on
nose and genital area. If rash, redness or itchiness results; discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep away from children. Package not child
resistant. In case of accidental ingestion, contact doctor immediately.
Directions
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
Other Information
Store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients
Water (Aqua), Alcohol Denat, Stearic Acid, Paraffinum Liquidum, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Glycereth-26, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Propylene Glycol, Diazolidinyl Urea, Stearyl Alcohol, Polysorbate 20, Triethanolamine, Cannabis Sativa Seed Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Benzotriazolyl Dodecyl p-Cresol, Methylparaben, Propylparaben, FD&C YELLOW No.5 (CI 19140), FD&C Blue No.1 (CI 42090).
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