Active Ingredient(S)
Methyl Salicylate 5% Purpose: Topical Analgesic
Topical Analgesic
FDA Label NDC 82165-102
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 82165-102). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, 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
Purpose
Topical Analgesic, Ointment
Use
For temporary relief minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
For External Use Only. Avoid contact with the eyes. Do not bandage tightly or apply to wounds or damaged skin.
Do Not Use
Do not Use on children under 16 years of age except on the advice of a physician.
Otc - When Using
Adults and children 16 years of age and older: Wash the affected area with mild soap and warm water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age consult a doctor.
Otc - Stop Use
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case accedental ingestion, get medical help or contact a Poison Control Center right away.
Directions
Apply to affected area not more than 3 to 4 times daily.
Other Information
- Store at controlled room temperature 15-30C (59-86F)
- Do not expose to excessive heat
Inactive Ingredients
Arnica, Camphor, D&C Brown #486, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, White Petrolatum.
Package Label - Principal Display Panel
2.5oz
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