Arnica Gel

Manufacturer
Sled Distribution, LLC
Effective date
2022-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:05:02

Label at a glance#

ProductArnica Gel
Active ingredientARNICA MONTANA
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana -7%

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

INDICATIONS & USAGE SECTION

Uses Temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls 
  • reduces symptoms of bruising such as : discoloration, pain, swelling.

WARNINGS SECTION

Warnings:

  • For external use only. Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Nursing mothers should not apply to breast area.
  • Keep out of reach of children.
  • Stop use and ask a doctor if: •symptoms worsen or do not improve within 3 days •skin irritation, redness or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions: Apply a thin layer of get to affected area as soon as possible after minor injure. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying ointment.

OTHER SAFETY INFORMATION

Other information:

  • Do not use if carton or tube seal is broken.

INACTIVE INGREDIENT SECTION

Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide

OTC - PURPOSE SECTION

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose

Arnica montana.......................................Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81417-123-012025-11-24C16284748780-10191ceaa-614b-198a-e063-dbdaa90aec3eArnica Gel
81417-123-012023-07-28C16284748780-10191ceaa-614b-198a-e063-dbdaa90aec3eArnica Gel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-123ARNICA GEL (ARNICA MONTANA) GEL [SLED DISTRIBUTION, LLC]1Legacy NDC20220325_adb355fa-8bc4-48f5-90ab-098d95dcfd1a.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-12381417-123-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
445c3379-d0e0-7420-e063-6294a90a574aadb355fa-8bc4-48f5-90ab-098d95dcfd1a2025-11-24WarningsExact identifier
spl set id: adb355fa-8bc4-48f5-90ab-098d95dcfd1a

Reported adverse events (FAERS/openFDA)#

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