Arnica Plus

Manufacturer: Peaceful Mountain, Inc. | Apotheca Company
Effective date: 2021-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 22:23:16

Label at a glance#

ProductArnica Plus

Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, TOXICODENDRON PUBESCENS LEAF

Label structure9 sections

Indications and uses

For temporary relief of 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.

Dosage and administration

Apply at least 3 times daily over the affected area.

Contacts and useful links#

PhoneLabel contact888-303-3388

Websitewww.peacefulmountain.com

www.peacefulmountain.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Toxicodendron 6X, 12X

INDICATIONS

OTC - PURPOSE SECTION

For temporary relief of 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 the product - Do not get into eyes. Stop use and ask a doctor if - Condition worsens Symptoms last more than 7 days.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply at least 3 times daily over the affected area.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Vera, Arnica (flower), Carbomer, Devil's Claw, Edetate Disodium, Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14, Peppermint (leaf), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ascorbic Acid, Vitamin E Oil, White Willow, Witch Hazel (bark)

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For temporary relief of 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.

QUESTIONS

OTC - QUESTIONS SECTION

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arnica plus

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

formulated in

boulder, co

Net wt. 3.7 oz. (105 g)

Arnica Plus

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43846-0032-1	2021-12-13	C162847	48780-1	9d75b9d0-ebcc-f424-e053-dadaa90a57ce	Drug Facts
43846-0032-1	2020-01-31	C162847	48780-1	9d75b9d0-ebcc-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	ACTIVE INGREDIENT	T7S323PKJS	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE INGREDIENT	6IO182RP7A	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	ACTIVE MOIETY	T7S323PKJS	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE MOIETY	6IO182RP7A	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
HAMAMELIS VIRGINIANA BARK	INACTIVE INGREDIENT	IH3063S9MY	1
HARPAGOPHYTUM PROCUMBENS ROOT	INACTIVE INGREDIENT	1OYM338E89	1
MENTHA PIPERITA	INACTIVE INGREDIENT	79M2M2UDA9	1
OREGANO	INACTIVE INGREDIENT	0E5AT8T16U	1
PEG-8 DIMETHICONE	INACTIVE INGREDIENT	GIA7T764OD	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	1
POLYETHYLENE GLYCOL 700	INACTIVE INGREDIENT	762678AC5R	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SALIX ALBA BARK	INACTIVE INGREDIENT	205MXS71H7	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

Arnica Plus
Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron
ARNICA MONTANA
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
TOXICODENDRON PUBESCENS LEAF
ALOE VERA LEAF
ARNICA MONTANA FLOWER
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
HARPAGOPHYTUM PROCUMBENS ROOT
EDETATE DISODIUM
OREGANO
POLYETHYLENE GLYCOL 1500
PEG-8 DIMETHICONE
POLYETHYLENE GLYCOL 700
MENTHA PIPERITA
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
POTASSIUM SORBATE
WATER
SODIUM HYDROXIDE
ASCORBIC ACID
.ALPHA.-TOCOPHEROL
SALIX ALBA BARK
HAMAMELIS VIRGINIANA BARK

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43846-0032	43846-0032-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ARNICA MONTANA	O80TY208ZW	ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	T7S323PKJS	ACTIB
TOXICODENDRON PUBESCENS LEAF	6IO182RP7A	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
HARPAGOPHYTUM PROCUMBENS ROOT	1OYM338E89	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
OREGANO	0E5AT8T16U	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
PEG-8 DIMETHICONE	GIA7T764OD	IACT
POLYETHYLENE GLYCOL 700	762678AC5R	IACT
MENTHA PIPERITA	79M2M2UDA9	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
SORBIC ACID	X045WJ989B	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
SALIX ALBA BARK	205MXS71H7	IACT
HAMAMELIS VIRGINIANA BARK	IH3063S9MY	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	DISC / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	ENEMA / RECTAL	0.44 %v/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVENOUS	2.78 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	78.36 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / PERIODONTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SUSPENSION, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6b257d83-ba62-4628-81e1-ce96e22c90b2			0fd26c95-0ee1-4213-b2d1-bf697f30c626	2021-12-13	Warnings	Exact identifier spl id: 6b257d83-ba62-4628-81e1-ce96e22c90b2 spl set id: 0fd26c95-0ee1-4213-b2d1-bf697f30c626

Reported adverse events (FAERS/openFDA)#

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