FDA.reportPublic FDA data

ARNICA MONTANA 30C

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-02-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:16:50

Label at a glance#

ProductARNICA MONTANA 30C
Active ingredientARNICA MONTANA
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​ACTIVE INGREDIENT (HPUS*):

Arnica Montana 30C

OTC - PURPOSE SECTION

​USES:​ Temporarily relieves aches, pains and bruising.**

INDICATIONS & USAGE SECTION

​USES: ​Temporarily relieves aches, pains and bruising.**

DOSAGE & ADMINISTRATION SECTION

​DIRECTIONS: ​Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​KEEP OUT OF THE REACH OF CHILDREN.​ In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

​WARNINGS:

  • ​Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask as health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

​INACTIVE INGREDIENTS: ​Purified Water, Ethyl Alcohol USP.

OTC - QUESTIONS SECTION

​QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600​​

REFERENCES SECTION

*​The letters "HPUS" indicate the component in the product is officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​NDC: 43406-0217-1

ARNICA MONTANA 30C

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0217-12022-02-17C16284748780-1d6a99b39-d3a3-a426-e053-dadaa90af4c2ARNICA MONTANA 30C
43406-0217-12022-01-28C16284748780-1d6a99b39-d3a3-a426-e053-dadaa90af4c2ARNICA MONTANA 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0217-1ARNICA MONTANA 30C30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0217ARNICA MONTANA 30C (ARNICA MONTANA) LIQUID [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20220218_bfbe4b3b-beed-4187-b82b-dc6dde07d91e.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-021743406-0217-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
ARNICA MONTANA 30CARNICA MONTANANatural Creations, Inc.bfbe4b3b-beed-4187-b82b-dc6dde07d91e2022-02-17WarningsExact identifier
ndc (package): 43406-0217-1
ndc (product): 43406-0217
ndc11 (package): 43406021701
spl id: 22e73b00-2289-4fb8-bb98-1834d76bc1c8
spl set id: bfbe4b3b-beed-4187-b82b-dc6dde07d91e

Reported adverse events (FAERS/openFDA)#

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