FDA.reportPublic FDA data

Arnica Pain Relief

Manufacturer
United Laboratories Manufacturing, LLC
Effective date
2022-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:48:07

Label at a glance#

ProductArnica Pain Relief
Active ingredientARNICA MONTANA
Label structure7 sections

Dosage and administration

Adults and children 2 years and above: Apply a thin layer to affected area and surrounding areas as soon as possible after injury. Lightly rub in and reapply after 30 seconds. Repeat 4 times a day for 3 to 5 days. When pain has subsided, apply once each morning and evening for continued temporary relief.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mountain arnica (Arnica montana) 3X HPUS

The letters 'HPUS' indicate thant the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Pain reliever

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, arthritis, and bruises.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

  • on open wounds 
  • cuts 
  • damaged skin
  • infected skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 7 days or worsens.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and above:
  • Apply a thin layer to affected area and surrounding areas as soon as possible after injury.
  • Lightly rub in and reapply after 30 seconds.
  • Repeat 4 times a day for 3 to 5 days.
  • When pain has subsided, apply once each morning and evening for continued temporary relief.

Other information:

SPL UNCLASSIFIED SECTION

Store tightly closed in a cool, dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera leaf juice, benzoic acid, carbomer 940, emu oil, eucalyptus oil, glycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, sodium hydroxide, sorbic acid

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62400-0034ARNICA PAIN RELIEF (ARNICA MONTANA) GEL [UNITED LABORATORIES MANUFACTURING, LLC]3Legacy NDC20221115_b6c081db-b56d-4eff-97ab-fd711bc162a4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62400-003462400-0034-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BENZOIC ACID8SKN0B0MIMIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
EMU OIL344821WD61IACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT

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
3f018f64-15e6-f754-e063-6294a90a4609b6c081db-b56d-4eff-97ab-fd711bc162a42025-09-17WarningsExact identifier
spl set id: b6c081db-b56d-4eff-97ab-fd711bc162a4

Reported adverse events (FAERS/openFDA)#

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