FDA.reportPublic FDA data

Arnica Montana

Manufacturer
Hyland's | STANDARD HOMEOPATHIC COMPANY
Effective date
2017-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:58

Label at a glance#

ProductArnica Montana
Active ingredientARNICA MONTANA
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Muscle Aches and Pains

WARNINGS SECTION

For external use only. Do not use on broken skin. If symptons persist for more than 7 days or worsen, consult a healthcare professional. Do not use if tamper band is broken or missing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Wash affected area with lukewarm water an d apply freely as needed, or as recomended by a licensed healthcare professional.

INACTIVE INGREDIENT SECTION

In base of Petrolatum USP with 5% Beeswax.

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 1X

OTC - PURPOSE SECTION

External use for symptomatic relief of muscle aches and pains due to overexertion and minor bruises from falls and sprains.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3327-1

Hyland's®

Homeopathic

Arnica Montana 1X

Muscle Aches and Pains

Homeopathic Ointment

13.5 OZ/405 GRAMS

0101

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-332754973-3327-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT

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
d39e2c27-71dd-8e59-e053-2a95a90a56ba54399c3c-2fa3-327d-e054-00144ff8d46c2021-12-20WarningsExact identifier
spl set id: 54399c3c-2fa3-327d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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