FDA.reportPublic FDA data

Arnica Active Roll-On

Manufacturer
Similasan Corporation
Effective date
2016-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:31

Label at a glance#

ProductArnica Active Roll-On
Active ingredientARNICA MONTANA
Label structure10 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • bruising & swelling • sprains • backaches • muscular aches & pains • strains • stiffness

Dosage and administration

For adults and children age 2 and over: Apply a thin layer to affected area soon as possible after minor injury. Repeat 3 times a day or as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Arnica Active® Roll-On

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 1X

Purpose

OTC - PURPOSE SECTION

bruises, swelling, aches, sprains, muscle pain, soreness, and stiffness

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• bruising & swelling
• sprains
• backaches
• muscular aches & pains
• strains
• stiffness

Warnings

WARNINGS SECTION

• FOR EXTERNAL USE ONLY. Do not use on damaged skin, open wounds, or mucous membranes.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• Avoid contact with the eyes.

• Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product’s inactive ingredients.

• Do not bandage tightly or use with a heating pad.

• If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children age 2 and over:

Apply a thin layer to affected area soon as possible after minor injury. Repeat 3 times a day or as needed.

Other Information

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

USP water, carbomer, sodium hydroxide, USP ethanol, PEG-8 dimethicone

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-102-42
Similasan
Arnica
Active
Roll-On
Pain Relief
74 ml/ 2.5 fl oz

PRINCIPAL DISPLAY PANEL NDC 59262-102-42 Similasan Arnica Active Roll-On Pain Relief 74 ml/ 2.5 fl ozPRINCIPAL DISPLAY PANEL NDC 59262-102-42 Similasan Arnica Active Roll-On Pain Relief 74 ml/ 2.5 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-102-422021-01-29C16284748780-1ba0f9c33-223d-a910-e053-dadaa90a0b85Arnica Active Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-102-42Arnica Active Roll-On74 mL in 1 APPLICATORLIQUID741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-102ARNICA ACTIVE ROLL-ON (ARNICA MONTANA) LIQUID [SIMILASAN CORPORATION]1Legacy NDC, 1 package rows20170201_2ff0363f-9d37-48b3-b97e-07154e04a1de.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-10259262-102-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
WATER059QF0KO0RIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
PEG-8 DIMETHICONEGIA7T764ODIACT

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
60a615bb-306b-450f-944f-eb5181daa33a2ff0363f-9d37-48b3-b97e-07154e04a1de2016-12-12WarningsExact identifier
spl id: 60a615bb-306b-450f-944f-eb5181daa33a
spl set id: 2ff0363f-9d37-48b3-b97e-07154e04a1de

Reported adverse events (FAERS/openFDA)#

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