FDA.reportPublic FDA data

Advanced Arnica

Manufacturer
King Bio Inc.
Effective date
2019-10-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:11:31

Label at a glance#

ProductAdvanced Arnica
Active ingredientARNICA MONTANA, ARNICA MONTANA ROOT
Label structure8 sections

Indications and uses

Uses temporarily relieves symptoms due to injury or overexertion: bruises muscle pain inflammation body aches sprains traumatic injury redness and swelling soreness after exercise rheumatic pain as per various homeopathic Materia Medicas. King Bio Inc. 3 Westside Drive Asheville, NC 28806 www.kingbio.com Reference image of arnica.jpg

Dosage and administration

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Adult Dose- 3 pump sprays 3 times per day. Use additionally as needed. Children 2-12 years- 2 pump sprays 3 times per day. Use additionally as needed. Reference image of arnica.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS active ingredients

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

Arnica montana

Arnica montana radix

Reference image of arnica.jpg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Arnica chamissonis flower extract,

Bio-Energetically Enhanced taste-free, pure water base.

Reference image of arnica.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult Dose- 3 pump sprays 3 times per day. Use additionally as needed.

Children 2-12 years- 2 pump sprays 3 times per day. Use additionally as needed.

Reference image of arnica.jpg

Purpose

OTC - PURPOSE SECTION

HPUS active ingredients Purpose

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

Arnica montana.......................................traumatic injury, sprains, bruises, body aches, muscle pain, inflammation

Arnica montana radix..............................redness and swelling, sensitivity to touch

Reference image of arnica.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses temporarily relieves symptoms due to injury or overexertion:

  • bruises
  • muscle pain
  • inflammation
  • body aches
  • sprains
  • traumatic injury
  • redness and swelling
  • soreness after exercise
  • rheumatic pain

as per various homeopathic Materia Medicas.



King Bio Inc.

3 Westside Drive

Asheville, NC 28806

www.kingbio.com



Reference image of arnica.jpg

Warnings

WARNINGS SECTION

Warnings If symptoms persist or worsen, seek advice of physician. If pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other Information Tamper resistant for your protection. Use only if safety seal is intact.

Reference image of arnica.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image of arnica.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


King Bio Inc.

3 Westside Drive

Asheville, NC 28806

www.kingbio.com

Reference image arnica.jpg

Image of carton labelImage of carton label


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5984-22021-01-29C16284748780-1ba0f9c33-1f49-a910-e053-dadaa90a0b85Advanced Arnica

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5984-2Advanced Arnica1 in 1 CARTONLIQUID14
57955-5984-2Advanced Arnica59 mL in 1 BOTTLE, SPRAYLIQUID594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5984ADVANCED ARNICA (NATURAL MEDICINE) LIQUID [KING BIO INC.]4Legacy NDC, 2 package rows20191009_b7d796f4-6f36-45cb-a037-b3e944aa56ec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW3
ARNICA MONTANA ROOTACTIVE INGREDIENTMUE8Y113273
ARNICA MONTANAACTIVE MOIETYO80TY208ZW3
ARNICA MONTANA ROOTACTIVE MOIETYMUE8Y113273
ARNICA CHAMISSONIS FLOWERINACTIVE INGREDIENT88WK5I8R3L3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-598457955-5984-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA CHAMISSONIS FLOWER88WK5I8R3LIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWACTIB
ARNICA MONTANA ROOTMUE8Y11327ACTIB

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
9468c413-f2a0-d4f3-e053-2995a90ae247b7d796f4-6f36-45cb-a037-b3e944aa56ec2019-10-08WarningsExact identifier
spl id: 9468c413-f2a0-d4f3-e053-2995a90ae247
spl set id: b7d796f4-6f36-45cb-a037-b3e944aa56ec

Reported adverse events (FAERS/openFDA)#

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