FDA.reportPublic FDA data

Arnicare Bruise

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-09-03 03:01:16

Label at a glance#

ProductArnicare Bruise
Active ingredientARNICA MONTANA
Label structure14 sections

Indications and uses

reduces symptoms of bruising such as: minor pain swelling discoloration

Dosage and administration

Adults and children 1 year of age and older: Apply a thin layer of Arnicare Bruise Gel to affected area and massage gently as soon as possible after minor bruise up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Bruise Gel. Children under 1 year of age: Not recommended.

Label contents#

Full prescribing information#

Active Ingredients**

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 1X HPUS 7%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose*

OTC - PURPOSE SECTION

Arnica montana 1X HPUS - Reduces minor pain, swelling & discoloration from bruises

Uses*

INDICATIONS & USAGE SECTION

reduces symptoms of bruising such as:

  • minor pain
  • swelling
  • discoloration

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes, mucus membranes, wounds, damaged or irritated skin
  • use only as directed
  • dryness or irritation may occur
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition persists for more than 3 days or worsens
  • symptoms clear up and occur again within a few days

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 1 year of age and older: Apply a thin layer of Arnicare Bruise Gel to affected area and massage gently as soon as possible after minor bruise up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Bruise Gel.
  • Children under 1 year of age: Not recommended.

Other information

SPL UNCLASSIFIED SECTION

  • do not use if glued carton end flaps are open or if the tube seal is broken
  • dispose of 1 year after opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, carbomer, purified water, sodium hydroxide

Questions, Comments?

OTC - QUESTIONS SECTION

Arnicare.com
BoironUSA.com
info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)

SPL UNCLASSIFIED SECTION

1.5 oz (45 g)

2.6 oz (75 g)

4.2 oz (120 g)

8.4 oz (204 g) 2 Tubes 4.2 oz (120 g)

Fragrance-Free

Quickly Absorbed

Fades Bruises

Distributed by Boiron Inc.
Newtown Square, PA 19073-3267

ɨ Homeopathic mother tincture made from Arnica montana fresh whole plant.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130306969084540GTIN-13: 0306969084540
EAN-13: 0306969084540
GTIN-12: 306969084540
UPC-A: 306969084540
GTIN storage (14 digits): 00306969084540		Arnicare Bruise ETU.1FS1 04.2020.jpg, box.jpg, Arnicare Bruise gel 1.5 ETU.1KJ1 02-25.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9084-542023-02-21C16284748780-1f386c649-c27c-0266-e053-dadaa90a7c1aArnicare Bruise
0220-9084-542023-02-21C16284748780-1f386c649-c27c-0266-e053-dadaa90a7c1aArnicare Bruise
0220-9084-542023-01-30C16284748780-1f386c649-c27c-0266-e053-dadaa90a7c1aArnicare Bruise
0220-9084-542023-01-30C16284748780-1f386c649-c27c-0266-e053-dadaa90a7c1aArnicare Bruise

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-9084-54GM - Gram0220-908410be5049-5d08-45d7-abcf-bb741113f1c212021-02-05

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90840220-9084-54, 0220-9084-59, 0220-9084-66, 0220-9084-85

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
ARNICA MONTANAO80TY208ZWACTIB
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-03-14full-release2026-06-01 02:32:36

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
Arnicare BruiseARNICA MONTANALaboratoires Boiron9d86cfb0-e155-4b0f-8bd0-ad5e8a3357072026-08-31WarningsExact identifier
ndc (package): 0220-9084-59
ndc (package): 0220-9084-54
ndc (package): 0220-9084-66
ndc (package): 0220-9084-85
ndc (product): 0220-9084
ndc11 (package): 00220908454
ndc11 (package): 00220908466
ndc11 (package): 00220908485
ndc11 (package): 00220908459
spl id: 5a5bfbba-f7b9-6a0c-e063-6394a90a219d
spl set id: 9d86cfb0-e155-4b0f-8bd0-ad5e8a335707

Reported adverse events (FAERS/openFDA)#

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