Otc - Active Ingredient
Menthol 3%
Camphor 3%
Menthol, Camphor Cream
FDA Label NDC 80465-003
12 label sections · Submitted to the FDA by Eros Global · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eros Global for the product Menthol, Camphor (NDC 80465-003). 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, indications & usage, warnings, otc - ask doctor, otc - when using, 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
External Analgesic
Indications & Usage
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.
Use only as directed.
Do not bandage tightly.
Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
If prone to allergic reaction to the product, consult to a doctor before using.
Otc - Ask Doctor
Ask a doctor before use if you have redness over affected area.
Otc - When Using
Avoid contact with eyes, mucous membranes, rashes.
Do not apply to wounds or damaged skin.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.
If rash, redness or itchiness results; discontinue use and consult a doctor.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast – feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Adults and children over 12 years of age
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 unless directed by a doctor.
Other Safety Information
Store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredient
Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Stearic Acid, Glycereth-26, Propylene Glycol, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Diazolidinyl Urea, Methylparaben, Propylparaben, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.
Cool Relief Cream
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