FDA.reportPublic FDA data

Topical Analgesic

Manufacturer
Dermaline USA Corp
Effective date
2022-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:22

Label at a glance#

ProductTopical Analgesic
Active ingredientMETHYL SALICYLATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

LabelLabelMethyl Salicylate 15%

OTC - PURPOSE SECTION

Topical Analgesic

INSTRUCTIONS FOR USE SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Roll On LabelArnica Roll On Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2260510methyl salicylate 15 % Topical OintmentPSN1
2260510methyl salicylate 0.15 MG/MG Topical OintmentSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82165-107-032024-01-30C16284748780-11030e365-3bab-111a-e063-dadaa90a10e2Dermaline 3 in1 Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-107-03Topical Analgesic85.05 g in 1 BOTTLE, WITH APPLICATOREMULSION85.051

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-107TOPICAL ANALGESIC (DERMALINE 3 IN 1 ROLL ON) EMULSION [DERMALINE USA CORP]1Legacy NDC, 1 package rows20220427_dd9432cf-9397-6a97-e053-2a95a90acfce.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82165-10782165-107-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
POLYSORBATE 207T1F30V5YHIACT
METHYL SALICYLATELAV5U5022YACTIB
TRIETHANOLAMINE MYRISTATE68B0CQC306IACT
TEA TREE OILVIF565UC2GIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
WATER059QF0KO0RIACT
DMDM HYDANTOINBYR0546TOWIACT
EUCALYPTUS OIL2R04ONI662IACT
CARBOMER 9404Q93RCW27EIACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CAPSICUM OLEORESINUW86K581WYIACT
ISOPROPYL ALCOHOLND2M416302IACT

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
dd9432cf-9398-6a97-e053-2a95a90acfcedd9432cf-9397-6a97-e053-2a95a90acfce2022-04-26WarningsExact identifier
spl id: dd9432cf-9398-6a97-e053-2a95a90acfce
spl set id: dd9432cf-9397-6a97-e053-2a95a90acfce

Reported adverse events (FAERS/openFDA)#

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