Active Ingredient(S)
Methyl Salicylate 15% . Purpose: Topical Analgesic
Topical Analgesic
FDA Label NDC 82165-101
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 82165-101). 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 - keep out of reach of children, pregnancy, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
For temporary relief of 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 costs.
Do Not Use
- On children under 16 years of age except on the advice of the physician.
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.
Pregnancy
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case accidental ingestion, get medical help or contact a Poision Control Center right away.
Directions
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.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat
Inactive Ingredients
Arnica, camphor, eucalyptus oil, D&C brown #486. Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum
Otc - Stop Use
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days.
Package Label - Principal Display Panel
2.5oz
* Please review the disclaimer below.
