FDA.reportPublic FDA data

Arnica Montana Nartex

Manufacturer
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV | LABORATORIOS HOMEOPATICOS SA DE CV
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:35:47

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.

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

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.

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.

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.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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


Questions or comments?

OTC - QUESTIONS SECTION

informacion@nartexlabs.com or call 1-800-838-0916 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.

Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by  Nartex.

Made in Mexico by:
NARTEX
Laboratorios Homeopaticos,
S.A. de C.V.
Calz. Lazaro Cardenas 708-770 Ote.
Col. Eduardo Guerra
Torreon, Coah. Mexico C.P. 27280
www.nartexlabs.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For external use only

Para uso externo solamente


NDC 34666-001-10

Homeopathic temporary relief for

the symptoms of Sore Muscles,

Bruises and Sprains.

Alivio temporal homeopatico para

los sintomas de Dolor Muscular,

Golpes y Torceduras.

Arnica and Hamamelis
Net Wt 1.05 oz (29.7 g)


Arnical 2012 CartonArnical 2012 Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130844627000018GTIN-13: 0844627000018
EAN-13: 0844627000018
GTIN-12: 844627000018
UPC-A: 844627000018
GTIN storage (14 digits): 00844627000018		Arnica2013label.jpg
BarcodeEAN-130844827000078GTIN-13: 0844827000078
EAN-13: 0844827000078
GTIN-12: 844827000078
UPC-A: 844827000078
GTIN storage (14 digits): 00844827000078		Arnica2013label.jpg
QR code linkQR Codewww.facebook.com/pages/Nartex-Labs/106317529472456Arnica2013label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-001-10Arnica Montana Nartex29.7 g in 1 TUBECREAM29.77
34666-001-10Arnica Montana Nartex1 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW4
HAMAMELIS VIRGINIANA LEAFACTIVE INGREDIENTT07U1161SV4
ARNICA MONTANAACTIVE MOIETYO80TY208ZW4
HAMAMELIS VIRGINIANA LEAFACTIVE MOIETYT07U1161SV4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
LANOLININACTIVE INGREDIENT7EV65EAW6H4
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
WATERINACTIVE INGREDIENT059QF0KO0R4

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
34666-00134666-001-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
GLYCERINPDC6A3C0OXIACT
PARAFFINI9O0E3H2ZEIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWACTIB
HAMAMELIS VIRGINIANA LEAFT07U1161SVACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 (package): 34666-001-10
ndc (product): 34666-001
ndc11 (package): 34666000110
spl id: 45b54da6-f73a-503c-e063-6394a90a96ea
spl set id: d1407fcf-ae2e-4dac-95bf-6a5f0b21f3a6
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 (product): 34666-001

Reported adverse events (FAERS/openFDA)#

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