FDA.reportPublic FDA data

Topical Analgesic

Manufacturer
Dermaline USA Corp
Effective date
2023-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:22

Label at a glance#

ProductTopical Analgesic
Active ingredientMETHYL SALICYLATE
Label structure12 sections

Dosage and administration

Apply to affected area not more than 3 to 4 times daily.

Storage and handling

Store at controlled room temperature 15-30C (59-86F) Do not expose to excessive heat

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Dermaline LabelDermaline LabelMethyl Salicylate 5% Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic, Ointment

Use

INDICATIONS & USAGE SECTION

For temporary relief 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 skin.

Do not use

OTC - DO NOT USE SECTION

Do not Use on children under 16 years of age except on the advice of a physician.

OTC - WHEN USING 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.

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children. In case accedental ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more than 3 to 4 times daily.

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15-30C (59-86F)
  • Do not expose to excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica, Camphor, D&C Brown #486, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, White Petrolatum.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label DisplayLabel Display2.5oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2569962methyl salicylate 5 % Topical OintmentPSN2
2569962methyl salicylate 0.05 MG/MG Topical OintmentSCD2
2569962methyl salicylate 5 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82165-102-022025-01-30C16284748780-1f386c64a-3b29-0266-e053-dadaa90a7c1aDermaline Arnica Salve Black
82165-102-022023-03-03C16284748780-1f386c64a-3b29-0266-e053-dadaa90a7c1aDermaline Arnica Salve Black
82165-102-022023-01-30C16284748780-1f386c64a-3b29-0266-e053-dadaa90a7c1aDermaline Arnica Salve Black

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-102-02Topical Analgesic70 g in 1 JAROINTMENT702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-102TOPICAL ANALGESIC (DERMALINE ARNICA SALVE BLACK) OINTMENT [DERMALINE USA CORP]2Legacy NDC, 1 package rows20230306_caf2318f-b320-74c6-e053-2a95a90a315d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82165-10282165-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
ARNICA MONTANAO80TY208ZWIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AIACT
MINERAL OILT5L8T28FGPIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
f601320e-064f-9b34-e053-2a95a90ac61bcaf2318f-b320-74c6-e053-2a95a90a315d2023-03-03WarningsExact identifier
spl id: f601320e-064f-9b34-e053-2a95a90ac61b
spl set id: caf2318f-b320-74c6-e053-2a95a90a315d

Reported adverse events (FAERS/openFDA)#

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