Topical Analgesic

Manufacturer
Dermaline USA Corp
Effective date
2023-02-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:10

Label at a glance#

ProductTopical Analgesic
Active ingredientMETHYL SALICYLATE
Label structure12 sections

Dosage and administration

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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 15% . Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

WARNINGS SECTION

For external use only. Avoid Contact with the eyes. Do not bandage tightly or apply to wounds or damaged costs.

Do not use

OTC - DO NOT USE SECTION

  • On children under 16 years of age except on the advice of the physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PREGNANCY SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica, camphor, eucalyptus oil, D&C brown #486. Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum

OTC - STOP USE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.5oz label2.5oz label2.5oz

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-101-02Topical Analgesic70 g in 1 JAROINTMENT703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-101TOPICAL ANALGESIC (DERMALINE ARNICA 3 IN 1) OINTMENT [DERMALINE USA CORP]3Legacy NDC, 1 package rows20230221_ca04b93b-3f46-71b1-e053-2995a90ac4c8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82165-10182165-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4aab735-de95-2ade-e053-2a95a90aea0aca04b93b-3f46-71b1-e053-2995a90ac4c82023-02-14WarningsExact identifier
spl id: f4aab735-de95-2ade-e053-2a95a90aea0a
spl set id: ca04b93b-3f46-71b1-e053-2995a90ac4c8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.