FDA.reportPublic FDA data

Arnica montana

Manufacturer
Newton Laboratories, Inc.
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:36:54

Label at a glance#

ProductArnica montana
Active ingredientARNICA MONTANA
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth, (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 30c.

OTC - PURPOSE SECTION

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

Warning:Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-9028-1Arnica montana30 mL in 1 BOTTLE, GLASSLIQUID301

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
55714-902855714-9028-1

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ARNICA MONTANAO80TY208ZWACTIB

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 MONTANANewton Laboratories, Inc.4976e279-cfa0-e8d8-e063-6294a90ab6402026-01-28WarningsExact identifier
ndc (package): 55714-9028-1
ndc (product): 55714-9028
ndc11 (package): 55714902801
spl id: 4976e290-2203-7932-e063-6394a90a189c
spl set id: 4976e279-cfa0-e8d8-e063-6294a90ab640

Reported adverse events (FAERS/openFDA)#

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