Soothing Advanced Arnica

Manufacturer: King Bio Inc. | Medical Products Laboratories, Inc.
Effective date: 2014-09-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:06:02

Label at a glance#

ProductSoothing Advanced Arnica

Active ingredientARNICA MONTANA, ARNICA MONTANA ROOT

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms:

pain or stiffness in muscles or joints
bruising and discoloration
inflammation
soreness after exercise

WARNINGS SECTION

Warnings

For external use only. Avoid contact with eyes and broken skin.
Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
Nursing mothers should not apply to breast area.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

•Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.

OTHER SAFETY INFORMATION

Other information:

To open: unscrew cap, remove tube seal, replace cap.
Safety sealed for your protection.
Do not use if tube seal is missing.
Store at 68-77° (20-25°C).

INACTIVE INGREDIENT SECTION

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, lemon oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lactylate, sweet almond oil.

OTC - PURPOSE SECTION

Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients Purpose

Equal volumes of each active ingredient in 6X, 30X, 6C, and LM1 potencies.

Active ingredients 50% of total weight.

Arnica montana................................................bruises, muscle pain, stiffness

Arnica montana, radix.......................................soreness after exercise, inflammation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57955-4000-3	2020-01-31	C162847	48780-1	9d75b9d0-cb44-f424-e053-dadaa90a57ce	Soothing Advanced Arnica™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57955-4000-3	Soothing Advanced Arnica	1 in 1 CARTON	CREAM	1		1
57955-4000-3	Soothing Advanced Arnica	85 g in 1 TUBE	CREAM	85		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57955-4000	SOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]	1	Legacy NDC, 2 package rows	20140929_ef8ef0f9-d09b-4066-87e3-1c9356730ead.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
ARNICA MONTANA ROOT	ACTIVE INGREDIENT	MUE8Y11327	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
ARNICA MONTANA ROOT	ACTIVE MOIETY	MUE8Y11327	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	1
ARNICA CHAMISSONIS FLOWER	INACTIVE INGREDIENT	88WK5I8R3L	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POMEGRANATE	INACTIVE INGREDIENT	56687D1Z4D	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SODIUM LACTATE	INACTIVE INGREDIENT	TU7HW0W0QT	1
SODIUM STEAROYL LACTYLATE	INACTIVE INGREDIENT	IN99IT31LN	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Soothing Advanced Arnica
Arnica montana, Arnica montana, radix
ARNICA MONTANA
ARNICA MONTANA ROOT
ARNICA CHAMISSONIS FLOWER
CETOSTEARYL ALCOHOL
WATER
GLYCERYL MONOSTEARATE
JOJOBA OIL
LEMON OIL
PHENOXYETHANOL
POMEGRANATE
SHEA BUTTER
SODIUM LACTATE
SODIUM STEAROYL LACTYLATE
ALMOND OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57955-4000	57955-4000-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ARNICA MONTANA	O80TY208ZW	ACTIB
ARNICA MONTANA ROOT	MUE8Y11327	ACTIB
ARNICA CHAMISSONIS FLOWER	88WK5I8R3L	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
WATER	059QF0KO0R	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
JOJOBA OIL	724GKU717M	IACT
LEMON OIL	I9GRO824LL	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POMEGRANATE	56687D1Z4D	IACT
SHEA BUTTER	K49155WL9Y	IACT
SODIUM LACTATE	TU7HW0W0QT	IACT
SODIUM STEAROYL LACTYLATE	IN99IT31LN	IACT
ALMOND OIL	66YXD4DKO9	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 1 · 49 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	INJECTION / INTRAVENOUS		54 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	SOLUTION / INTRAPERITONEAL	0.45 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	INJECTION, SOLUTION / INFILTRATION	0.17 %v/v		Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	18.7 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	SUSPENSION / ORAL	20 mg/1ml		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	PASTE, DENTIFRICE / DENTAL	0.7 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ALMOND OIL	ALMOND OIL	66YXD4DKO9	CREAM / TOPICAL	2 %w/w		Exact identifier — unii candidate
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM LACTATE	SODIUM LACTATE	TU7HW0W0QT	SOLUTION / TOPICAL	0.93 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 4 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
18d7a8c6-5e51-4510-a7fd-8be1e50d5a0a			ef8ef0f9-d09b-4066-87e3-1c9356730ead	2014-09-29	Warnings	Exact identifier spl id: 18d7a8c6-5e51-4510-a7fd-8be1e50d5a0a spl set id: ef8ef0f9-d09b-4066-87e3-1c9356730ead

Reported adverse events (FAERS/openFDA)#

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