Dermaline Arnica Gel

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 23:54:11

Label at a glance#

ProductTopical Analgesic
Active ingredientMENTHOL
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 yeats of age: consult a doctor.

Storage and handling

Store between 15-30C (59-86F) Do not expose to excessive heat.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%. Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic, Gel

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flames.

Avoid Contact with eyes. Do not bandage tightly.

Do not apply over large areas of the body.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Incase accidental ingestion, get medical help or contact a Poison Control Center right away.

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.

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 yeats of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Do not expose to excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica Extract, Camphor, Carbomer, Deionized Water, DMDM Hydatoin, Ethyl Alcohol, Eucalyptus Oil, Isopropyl Alcohol, Nonoxynol-9, polysorbate 20, propyleneglycol, Tea Tree Oil, Trirthanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel141 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039043menthol 1 % Topical GelPSN3
1039043menthol 0.01 MG/MG Topical GelSCD3
1039043menthol 1 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82165-104-052025-01-30C16284748780-1f386c649-9fc1-0266-e053-dadaa90a7c1aDermaline Arnica Gel
82165-104-052023-02-01C16284748780-1f386c649-9fc1-0266-e053-dadaa90a7c1aDermaline Arnica Gel
82165-104-052023-01-30C16284748780-1f386c649-9fc1-0266-e053-dadaa90a7c1aDermaline Arnica Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-104-05Topical Analgesic141 g in 1 JARGEL1413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-104TOPICAL ANALGESIC (DERMALINE ARNICA MENTHOL GEL) GEL [DERMALINE USA CORP]3Legacy NDC, 1 package rows20230221_d03cec22-7ac1-747c-e053-2995a90a87db.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82165-10482165-104-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
f4aab3cb-e7eb-1f9f-e053-2a95a90ae583d03cec22-7ac1-747c-e053-2995a90a87db2023-02-14WarningsExact identifier
spl id: f4aab3cb-e7eb-1f9f-e053-2a95a90ae583
spl set id: d03cec22-7ac1-747c-e053-2995a90a87db

Reported adverse events (FAERS/openFDA)#

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