Arnica montana

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-05-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:27:00

Label at a glance#

ProductArnica montana
Active ingredientARNICA MONTANA
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient** (in each pellet)

Arnica montana 200CK HPUS (0.44 mg)

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*

Arnica montana 200CK HPUS (0.44 mg) ... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves minor muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls

reduces symptoms of bruising such as:

  • pain
  • swelling
  • discoloration

OTC - STOP USE SECTION

Box: Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be a sign of a serious condition.

Tube: Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Box: If pregnant or breast-feeding, ask a health professional before use.

Tube: If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Box: Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Tube: Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Box:

Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

3 Tubes

Approx 80 pellets each

Total 240 pellets
16 Doses per tube

No known drug interactions

Plant-Powered Relief

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

Meltaway Pellets
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue

Tube:

Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

*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

lactose, sucrose

DOSAGE & ADMINISTRATION SECTION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

OTC - QUESTIONS SECTION

Arnicare.com

BoironUSA.com

Info@Boiron.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-0502-41Arnica montana200 [kp_C] in 1 TUBEPELLET2004
0220-0502-43Arnica montana3 in 1 BOXPELLET34
0220-0502-43Arnica montana200 [kp_C] in 1 TUBEPELLET2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-0502ARNICA MONTANA (ARNICA MONTANA ) PELLET [BOIRON]4Current NDC, Legacy NDC, 3 package rows20240522_84ee5fbf-7252-4b8a-e053-2a91aa0aa159.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-05020220-0502-41, 0220-0502-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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 montanaARNICA MONTANABoiron84ee5fbf-7252-4b8a-e053-2a91aa0aa1592024-05-21Exact identifier
ndc (package): 0220-0502-41
ndc (package): 0220-0502-43
ndc (product): 0220-0502
ndc11 (package): 00220050241
ndc11 (package): 00220050243
spl id: 18f8acf3-94e5-8132-e063-6394a90a2cc1
spl set id: 84ee5fbf-7252-4b8a-e053-2a91aa0aa159

Reported adverse events (FAERS/openFDA)#

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