FDA.reportPublic FDA data

Arnicated Oil

Manufacturer
Hyland's | Standard Homeopathic Company
Effective date
2017-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:32

Label at a glance#

ProductArnicated Oil
Active ingredientARNICA MONTANA
Label structure7 sections

Indications and uses

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

Dosage and administration

Apply freely to area.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 1X

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply freely to area.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on broken skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

Do not use if tamper band is broken or missing.

OTC - PURPOSE SECTION

Muscle aches and pains

INACTIVE INGREDIENT SECTION

Mineral Oil USP

PRINCIPAL DISPLAY PANEL - 4 FL.OZ. BOTTLE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-1156-2

HOMEOPATHIC

Hyland's®

Arnicated

Oil

Muscle Aches and Pains

Homeopathic

4 FL. OZ./120 ML.

LabelLabel

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
54973-115654973-1156-2, 54973-1156-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
MINERAL OILT5L8T28FGPIACT

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
d39e1ee9-8c69-21c1-e053-2995a90a49135f366d65-394a-4255-e053-2991aa0ae9ef2021-12-20WarningsExact identifier
spl set id: 5f366d65-394a-4255-e053-2991aa0ae9ef

Reported adverse events (FAERS/openFDA)#

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