FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2026-07-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-04 03:32:26

Label at a glance#

ProductArnica Plus
Active ingredientARNICA MONTANA WHOLE, 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

0.17% of 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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 • Conditions 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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Arnica (Arnica Montana) Flower, White Willow (Salix Alba) Bark, Witch Hazel (Hamamelis Virginiana) Bark, Ascorbic Acid, Devil’s Claw (Harpagophytum Procumbens) Root, Peppermint (Mentha Piperita) Leaf, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Peg-33, Peg-8 Dimethicone, Peg-14, Sodium Hydroxide, Tocopherols (soy), Disodium EDTA, Natural Plant Extract, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arnica plus

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

Net wt. 2 oz. (57 g)

Arnica PlusArnica Plus

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0075-12023-08-07C16284748780-1f386c649-c9ee-0266-e053-dadaa90a7c1aDRUG FACTS:
43846-0075-12023-08-07C16284748780-1f386c649-c9ee-0266-e053-dadaa90a7c1aDRUG FACTS:
43846-0075-12023-01-30C16284748780-1f386c649-c9ee-0266-e053-dadaa90a7c1aDRUG FACTS:
43846-0075-12023-01-30C16284748780-1f386c649-c9ee-0266-e053-dadaa90a7c1aDRUG FACTS:

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-007543846-0075-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA WHOLEO80TY208ZWACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
EDETATE DISODIUM7FLD91C86KIACT
OREGANO0E5AT8T16UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
SALIX ALBA BARK205MXS71H7IACT
HAMAMELIS VIRGINIANA BARKIH3063S9MYIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
MENTHA PIPERITA LEAFA389O33LX6IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42023-08-07full-release2026-06-01 02:21:59

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
828028eb-6b80-4656-a3cd-40894895b312613ddf6c-ba89-4b98-8576-d2cd38f6910a2026-07-31WarningsExact identifier
spl id: 828028eb-6b80-4656-a3cd-40894895b312
spl set id: 613ddf6c-ba89-4b98-8576-d2cd38f6910a

Reported adverse events (FAERS/openFDA)#

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