Arnica Active Montana Nartex

Manufacturer
Nartex Laboratorios Homeopaticos, S.A. de C.V.
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:34

Label at a glance#

ProductArnica Active Montana Nartex
Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
Label structure9 sections

Indications and uses

Temporary relief for the symptoms of sore muscles, bruises and sprains. Claims based on traditional homeopathic practice, not accepted medical evidence. The uses have not been evaluated by FDA, and product has not been clinically tested.

Dosage and administration

adults and children over 2 years of age: apply generously rubbing into affected area as needed. children 2 years of age: consult a physician.

Storage and handling

do not use if the tube seal is broken or missing store at room temperature

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Each dose contains equal parts of:

Arnica montana TINC HPUS*

Hamamelis virginia TINC HPUS*

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC is an homeopathic dilution. See www.nartexlabsusa.com for more information.

Purpose

OTC - PURPOSE SECTION

Each dose contains equal parts of:

Arnica montana TINC HPUS*..................Anti-inflammatory/Pain relief

Hamamelis virginia TINC HPUS*.........................Anti-inflammatory/Pain relief

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC is an homeopathic dilution. See www.nartexlabsusa.com for more information.

Uses

INDICATIONS & USAGE SECTION

Temporary relief for the symptoms of sore muscles, bruises and sprains.

Claims based on traditional homeopathic practice, not accepted medical evidence. The uses have not been evaluated by FDA, and product has not been clinically tested.

Warnings

WARNINGS SECTION

For external use only.

Warnings

OTC - DO NOT USE SECTION

Do not

  • apply to wounds or damaged skin
  • apply over large areas of the body

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, consult a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children over 2 years of age: apply generously rubbing into affected area as needed.
  • children 2 years of age: consult a physician.

Other information

STORAGE AND HANDLING SECTION

  • do not use if the tube seal is broken or missing
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Carbomer, Menthol (fragrance), Purified water, Sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New

NDC 34666-407-01

Arnica Active Montana Nartex

Gel

Homeopathic temporary relief for the symptoms of Sore Muscles, Bruises and Sprains.

Arnica & Hamamelis

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

Paraben Free

Non-Greasy

With menthol as fragrance

Homeopathic

Absorbs quickly

For external use only

contains Witch Hazel

Hamamelis

Net Wt. 2.6 oz (74 g)

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-407-01Arnica Active Montana Nartex1 in 1 CARTONGEL11
34666-407-01Arnica Active Montana Nartex74 g in 1 TUBEGEL741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-407ARNICA ACTIVE MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) GEL [NARTEX LABORATORIOS HOMEOPATICOS, S.A. DE C.V.]1Current NDC, Legacy NDC, 2 package rows20211231_d469fd01-4a37-3e63-e053-2a95a90a0a66.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-40734666-407-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 Active Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANartex Laboratorios Homeopaticos, S.A. de C.V.d469fd01-4a37-3e63-e053-2a95a90a0a662021-12-30WarningsExact identifier
ndc (package): 34666-407-01
ndc (product): 34666-407
ndc11 (package): 34666040701
spl id: d469fd01-4a38-3e63-e053-2a95a90a0a66
spl set id: d469fd01-4a37-3e63-e053-2a95a90a0a66

Reported adverse events (FAERS/openFDA)#

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