Arnica Montana Nartex Cream

Manufacturer
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV | LABORATORIOS HOMEOPATICOS SA DE CV
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:15:28

Label at a glance#

ProductArnica Montana Nartex
Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA LEAF
Label structure10 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. These 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

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each dose contains equal parts of:

Arnica montana TINC HPUS*

Hamamelis virginiana TINC HPUS*

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

Purpose

OTC - PURPOSE SECTION

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



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

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. These uses have not been evaluated by FDA, and product has not been clinically tested.

Warnings

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTHER SAFETY INFORMATION

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Lanolin wax, Paraffin, Sodium benzoate, Water, White petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

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

DESCRIPTION SECTION

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.



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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For external use only

Arnica Montana Nartex Cream

Net Wt. 3.52 oz

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.

Homeopathic

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-001-20Arnica Montana Nartex1 in 1 CARTONCREAM12
34666-001-20Arnica Montana Nartex99.79 g in 1 TUBECREAM99.792

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-001ARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINIANA) CREAM [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]2Current NDC, Legacy NDC, 2 package rows20211230_cd114ace-c040-9e1b-e053-2a95a90a418b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-00134666-001-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVd1407fcf-ae2e-4dac-95bf-6a5f0b21f3a62025-12-11WarningsExact identifier
ndc (product): 34666-001
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVd63b84e1-24c1-6c6c-e053-2995a90a22ce2022-01-23WarningsExact identifier
ndc (product): 34666-001
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINIANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVcd114ace-c040-9e1b-e053-2a95a90a418b2021-12-29WarningsExact identifier
ndc (package): 34666-001-20
ndc (product): 34666-001
ndc11 (package): 34666000120
spl id: d4555a15-6cee-3fa0-e053-2995a90a379b
spl set id: cd114ace-c040-9e1b-e053-2a95a90a418b

Reported adverse events (FAERS/openFDA)#

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