FDA.reportPublic FDA data

Arnicare Bruise Cream

Manufacturer
Boiron | Boiron Inc.
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-09-03 03:01:30

Label at a glance#

ProductArnicare Bruise
Active ingredientARNICA MONTANA
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient**

Arnica montana 1X HPUS 7%

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

OTC - PURPOSE SECTION

Purpose*

Reduces minor pain, swelling, & discoloration from bruises

INDICATIONS & USAGE SECTION

Uses*

reduces symptoms of bruising such as:

  • minor pain
  • swelling
  • discoloration

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, mucous membranes, wounds, damaged or irritated skin
  • use only as directed
  • 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 - ASK DOCTOR 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 1 year of age and older: Apply a thin layer of Arnicare Bruise Cream 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 Cream.
  • Children under 1 year of age: Not recommended.

SPL UNCLASSIFIED SECTION

Other information

  • do not use if glued carton end flaps are open
  • dispose of 1 year after opening

1.4 oz (40 g)

2.5 oz (70 g)

4.2 oz (120 g)

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

Bruise Relief*

Pain Swelling Discoloration*

Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073

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.

INACTIVE INGREDIENT SECTION

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

Arnicare.com | BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabelLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABEL

1g451g451g461g46

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130306969085127GTIN-13: 0306969085127
EAN-13: 0306969085127
GTIN-12: 306969085127
UPC-A: 306969085127
GTIN storage (14 digits): 00306969085127		Arnicare Bruise Cream ETU.1G45 10.2020.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9085-602023-03-20C16284748780-1f386c64a-2e66-0266-e053-dadaa90a7c1aArnicare Bruise Cream
0220-9085-602023-03-20C16284748780-1f386c64a-2e66-0266-e053-dadaa90a7c1aArnicare Bruise Cream
0220-9085-602023-03-20C16284748780-1f386c64a-2e66-0266-e053-dadaa90a7c1aArnicare Bruise Cream
0220-9085-602023-01-30C16284748780-1f386c64a-2e66-0266-e053-dadaa90a7c1aArnicare Bruise Cream
0220-9085-602023-01-30C16284748780-1f386c64a-2e66-0266-e053-dadaa90a7c1aArnicare Bruise Cream
0220-9085-602023-01-30C16284748780-1f386c64a-2e66-0266-e053-dadaa90a7c1aArnicare Bruise Cream

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90850220-9085-60, 0220-9085-63, 0220-9085-82, 0220-9085-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
DOCOSANOL9G1OE216XYIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
COCONUT OILQ9L0O73W7LIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-05-20full-release2026-06-01 02:38:40
82025-12-11monthly-update2026-06-03 17:44:53

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 MONTANABoironb957a592-e51b-61fc-e053-2995a90aaabd2026-08-31WarningsExact identifier
ndc (package): 0220-9085-82
ndc (package): 0220-9085-88
ndc (package): 0220-9085-63
ndc (package): 0220-9085-60
ndc (product): 0220-9085
ndc11 (package): 00220908588
ndc11 (package): 00220908560
ndc11 (package): 00220908563
ndc11 (package): 00220908582
spl id: 5a5dab23-29e6-ed7f-e063-6394a90a2d28
spl set id: b957a592-e51b-61fc-e053-2995a90aaabd

Reported adverse events (FAERS/openFDA)#

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