FDA.reportPublic FDA data

BM Arnica Ointment

Manufacturer
BM Private Limited
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:35:39

Label at a glance#

ProductBM Arnica
Active ingredientCINNAMON OIL, ARNICA MONTANA FLOWER, CAMPHOR (NATURAL), CLOVE OIL, MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Storage and handling

Storage: Store in a cool, dry place below 30°C (86°F). Protect from direct sunlight.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Arnica mont 1X (HPUS)

Camphora 8X (HPUS)

Cinnamomum 1X (HPUS)

Mantholum 1X (HPUS)

Syz. Aroma 1X (EHPI)

OTC - PURPOSE SECTION

Active ingredients Purpose*

Arnica mont 1X (HPUS)............pain

Camphora 8X (HPUS)..............muscle soreness

Cinnamomum 1X (HPUS)........poor circulation

Mantholum 1X (HPUS).............pain and swelling

Syz. Aroma 1X (EHPI)............localized nerve pain

INDICATIONS & USAGE SECTION

Uses*

Helps temporarily relieve: minor aches; occasional muscle and joint aches; stiffness; swelling; discomfort; soreness

WARNINGS SECTION

Warnings:

For external use only.

Avoid contact with eyes and mucous membranes.

Keep out of reach of children.

If you have severe symptoms, consult a doctor before use.

Do not use on broken or damaged skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings:

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions:

Use as directed.

Clean the affected area before application.

Apply a thin layer to the affected area, 2-3 times daily or as directed by a physician.

STORAGE AND HANDLING SECTION

Storage:

Store in a cool, dry place below 30°C (86°F).

Protect from direct sunlight.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Cetostearyl alcohol, Paraffin oil, White soft paraffin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube

tubetube

Box

boxbox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6029-1BM Arnica40 g in 1 TUBEOINTMENT402

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85816-602985816-6029-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CINNAMON OILE5GY4I6YCZACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
MINERAL OILT5L8T28FGPIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CLOVE OIL578389D6D0ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
BM ArnicaARNICA MONTANABM Private Limited450d5924-0d5d-e013-e063-6394a90a76bb2025-12-05WarningsExact identifier
ndc (package): 85816-6029-1
ndc (product): 85816-6029
ndc11 (package): 85816602901
spl id: 453354dc-29d5-0601-e063-6394a90a0d91
spl set id: 450d5924-0d5d-e013-e063-6394a90a76bb

Reported adverse events (FAERS/openFDA)#

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