Otc - Active Ingredient
Menthol 3%
Camphor 3%
Menthol, Camphor Cream
FDA Label NDC 80465-003
Full FDA labeling including 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, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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