FDA.reportPublic FDA data

ARNICA MONTANA 200C

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 02:16:47

Label at a glance#

ProductARNICA MONTANA 200C
Active ingredientARNICA MONTANA
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (HPUS*):

Arnica Montana 200C

OTC - PURPOSE SECTION

USES: Temporarily relieves aches & pains from bruising & sore muscles.**

INDICATIONS & USAGE SECTION

USES: Temporarily relieves aches & pains from bruising & sore muscles.**

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

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF HTE 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.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF HTE 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: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

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

REFERENCES SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0311-1

ARNICA

MONTANA 200C

 HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0311-12022-02-17C16284748780-1d6a99b39-8665-a426-e053-dadaa90af4c2ARNICA MONTANA 200C
43406-0311-12022-01-28C16284748780-1d6a99b39-8665-a426-e053-dadaa90af4c2ARNICA MONTANA 200C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0311-1ARNICA MONTANA 200C30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0311ARNICA MONTANA 200C (ARNICA MONTANA) LIQUID [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20220218_636259e7-0f80-4fbf-b1d7-896377f7cee4.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
43406-031143406-0311-1

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
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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 200CARNICA MONTANANatural Creations, Inc.636259e7-0f80-4fbf-b1d7-896377f7cee42022-02-17WarningsExact identifier
ndc (package): 43406-0311-1
ndc (product): 43406-0311
ndc11 (package): 43406031101
spl id: a38d1ef6-192a-4447-b254-d0f31b966dc1
spl set id: 636259e7-0f80-4fbf-b1d7-896377f7cee4

Reported adverse events (FAERS/openFDA)#

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