Otc - Active Ingredient
Methyl Salicylate 15%
Topical Analgesic
FDA Label NDC 82165-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermaline Usa Corp for the product Topical Analgesic (NDC 82165-107). 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, instructions for use, warnings, otc - do not use, indications & usage, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Instructions For Use
Uses: For temporary relief of minor aches and pains of muscles and joints, such as simple backahe, lumbago, arthritis, neuralgia, strains, bruises, and sprains
Warnings
Warning: External use only. Keep out of reach of children. Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.
Otc - Do Not Use
Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.
Indications & Usage
Directions: Adult and children 16 years and older. Wash affected area with mild soap and warm water and rinse throughly. Apply a small amount of Dermaline Arnica Ointment to the affected area 1 to 3 times daily.
Inactive Ingredient
Camphor, Capsicum Extract, Carbomer, Deionized Water, DMDM hydantoin, Eucalyptus Oil, Isopropyl Alcohol, Menthol, Polysorbate 20, Propyleneglycol, Tocopherol Acetate, Triethanolamine, Tea Tree Oil
Other Safety Information
Store at room temperature. 15 - 30 degrees C (59-86 degrees F). Avoid excessive heat & humidity
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
Directions: Adult and children 16 years and older. Wash affected area with mild soap and warm water and rinse throughly. Apply a small amount of Dermaline Arnica Ointment to the affected area 1 to 3 times daily.
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