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 Eros Global. 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
Menthol 3%
Camphor 3%
Otc - Purpose
Menthol 3%……………………...…………………. PURPOSE: External Analgesic
Camphor 3% ...................................................... PURPOSE: Pain Relieving
Indications & Usage
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.
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
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.
Otc - Keep Out Of Reach Of Children
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.
Inactive Ingredient
Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, FD&C Blue 1 Powder (CI 42090)
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