FDA.reportPublic FDA data

Arnica Plus

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2016-09-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:08:11

Label at a glance#

ProductArnica Plus
Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Dosage and administration

Apply at least 3 times daily over the affected area.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve minor symptoms of sore, overexerted muscles.**


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

WARNINGS:

WARNINGS SECTION

For external use only. If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product • Do not get into eyes. Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days.

Do not use if safety seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply at least 3 times daily over the affected area.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve minor symptoms of sore, overexerted muscles.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Purified Water, Grapeseed (Seed) Carrier Oil, Whey Protein Concentrate, Lecithin (Soy) (Liquid)Sodium Hydroxide (Solution), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Arnica (flower), Aloe Barbadensis Leaf Juice, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Polysorbate 20, Tocopherol [Vitamin E Oil], Peppermint (leaf), Edetate Disodium (EDTA), Natural plant extract (Origanox WS), Potassium Sorbate.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arnica

plus®

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

formulated in

boulder, co

Net wt. 2 oz. (57g)

Arnica PlusArnica Plus

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0060-12020-02-04C16284748780-19d75b9d0-4c03-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43846-0060-1Arnica Plus57 g in 1 TUBEGEL572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0060ARNICA PLUS (ARNICA MONTANA, HAMAMELIS VIRGINIANA, RHUS TOX) GEL [PEACEFUL MOUNTAIN, INC.]2Legacy NDC, 1 package rows20160930_d5cac1bc-b443-4518-b5b3-8188c2d00926.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-006043846-0060-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
WATER059QF0KO0RIACT
GRAPE SEED OIL930MLC8XGGIACT
WHEY8617Z5FMF6IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ALOE VERA LEAFZY81Z83H0XIACT
SALIX ALBA BARK205MXS71H7IACT
HAMAMELIS VIRGINIANA BARKIH3063S9MYIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
POLYSORBATE 207T1F30V5YHIACT
TOCOPHEROLR0ZB2556P8IACT
MENTHA PIPERITA79M2M2UDA9IACT
EDETATE DISODIUM7FLD91C86KIACT
OREGANO0E5AT8T16UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
cc9415ce-40e7-492a-8743-83cd01ee5e46d5cac1bc-b443-4518-b5b3-8188c2d009262016-09-29WarningsExact identifier
spl id: cc9415ce-40e7-492a-8743-83cd01ee5e46
spl set id: d5cac1bc-b443-4518-b5b3-8188c2d00926

Reported adverse events (FAERS/openFDA)#

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