FDA.reportPublic FDA data

Arnicare Foot Care

Manufacturer
Boiron | Boiron Inc.
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:35:11

Label at a glance#

ProductArnicare Foot Care
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 components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Relieves minor muscle pain & soreness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves symptoms of overexertion and minor muscle and joint injuries such as:

  • sore feet
  • aches
  • pains
  • reduces symptoms of sprains and strains such as:
  • minor pain
  • swelling
  • discoloration from bruises

WARNINGS SECTION

Warnings

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 - STOP USE SECTION

Stop use and ask a doctor if

  • condition persists for more than 3 days or worsen
  • 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 Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

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

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

4.2 oz (120g)

Sore & Aching Feet Swelling from Sprains Joint Pain*

Foot Pain Relief*

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

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

Newtown Square, PA 19073-3267

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ETU.1K67ETU.1K67TUP.1K69TUP.1K69ETU.1FSEETU.1FSE

TUL.1FSFTUL.1FSFETUETUTULTUL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9055-822023-05-23C16284748780-1f386c649-c1b4-0266-e053-dadaa90a7c1aArnicare Foot Care
0220-9055-822023-01-30C16284748780-1f386c649-c1b4-0266-e053-dadaa90a7c1aArnicare Foot Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9055-82Arnicare Foot Care1 in 1 PACKAGECREAM19
0220-9055-82Arnicare Foot Care1 [hp_X] in 1 TUBECREAM19

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
0220-90550220-9055-82

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
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
COCONUT OILQ9L0O73W7LIACT
GLYCERINPDC6A3C0OXIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT

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
Arnicare Foot CareARNICA MONTANABoiron6b3c511c-7b11-203f-e053-2991aa0a6e012025-11-14WarningsExact identifier
ndc (package): 0220-9055-82
ndc (product): 0220-9055
ndc11 (package): 00220905582
spl id: 4392ec6d-d9fc-80bd-e063-6294a90a7355
spl set id: 6b3c511c-7b11-203f-e053-2991aa0a6e01

Reported adverse events (FAERS/openFDA)#

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