FDA.reportPublic FDA data

Arnica gel

Manufacturer
WALGREENS
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:44

Label at a glance#

ProductArnica gel
Active ingredientARNICA MONTANA
Label structure10 sections

Indications and uses

temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls reduces pain, swelling and discoloration from bruises

Dosage and administration

Apply a thin layer of gel to affected area and massage gently as soon as possible after minor injury. Repeat 3 times a day or as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana

1X HPUS 7%

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Carbomer, Purified water, Sodium Hydroxide

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of gel to affected area and massage gently as soon as possible after minor injury. Repeat 3 times a day or as needed.

Uses*

INDICATIONS & USAGE SECTION

  • temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls
  • reduces pain, swelling and discoloration from bruises

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes, mucous membranes, damaged skin, or wounds.

Do not use if you are allergic to Arnica montana or to any of thus product's inactive ingredients.

When using this product

  • use only as directed
  • do not bandage tightly or use a heating pad.

Stop use and ask a doctor if condition persists for more than 3 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.

OTC - PURPOSE SECTION

Trauma, muscle pain, and, stiffness, swelling from injuries, discoloration from bruising

Other information

OTHER SAFETY INFORMATION

  • Do not use if glued carton end flaps are open or if the tube seal is broken,
  • Store at 68-77 F (20-25 C)

Questions or comments?

OTC - QUESTIONS SECTION

1-800-925-4733

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0139-26Arnica gel74 g in 1 PACKAGEGEL742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0139ARNICA GEL (ARNICA) GEL [WALGREENS]2Current NDC, Legacy NDC, 1 package rows20210717_b60f9c58-9908-6184-e053-2a95a90aa435.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
0363-01390363-0139-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWACTIB

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
Arnica gelARNICAWALGREENSb60f9c58-9908-6184-e053-2a95a90aa4352021-07-15WarningsExact identifier
ndc (package): 0363-0139-26
ndc (product): 0363-0139
ndc11 (package): 00363013926
spl id: c7171929-a9a4-5078-e053-2995a90a560e
spl set id: b60f9c58-9908-6184-e053-2a95a90aa435

Reported adverse events (FAERS/openFDA)#

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