FDA.reportPublic FDA data

Arnica Montana Nartex

Manufacturer
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
Effective date
2018-12-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:10:39

Label at a glance#

ProductArnica Montana Nartex
Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA LEAF
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana TINC

Hamamelis virginica TINC

OTC - PURPOSE SECTION

Anti-inflammatory, pain reliever

INDICATIONS & USAGE SECTION

for the temporary relief of

  • sore muscles
  • bruises
  • sprains

as per homeopathic materia medica

WARNINGS SECTION

Warnings:

For external use only.

OTC - DO NOT USE SECTION

Do not:

  • use if you have an allergy or hypersensitivity to components of the formula
  • apply to wounds or damaged skin
  • apply to children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if:

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

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.

DOSAGE & ADMINISTRATION SECTION

  • adults and children over 2 years of age and older: apply generously rubbing into the affected area
  • reapply if needed
  • children under 2 years of age: consult a physician

INACTIVE INGREDIENT SECTION

Glycerin, Lanolin wax, Sodium benzoate, Solid petrolatum, water

OTC - QUESTIONS SECTION

Questions or comments?

P.O. Box 1261, Downey CA 90240

www.nartexlabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Homeopathic relief for sore muscles, bruises and sprains.

Arnica Montana Nartex CartonArnica Montana Nartex Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-007-16Arnica Montana Nartex16 g in 1 CONTAINEROINTMENT167
34666-007-28Arnica Montana Nartex28 g in 1 CONTAINEROINTMENT287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-007ARNICA MONTANA NARTEX (ARNICA MONTANA, HAMAMELIS VIRGINICA) OINTMENT [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]7Current NDC, Legacy NDC, 2 package rows20181228_3d2355e3-7ab8-4e4b-b811-38f33336212d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW6
HAMAMELIS VIRGINIANA LEAFACTIVE INGREDIENTT07U1161SV6
ARNICA MONTANAACTIVE MOIETYO80TY208ZW6
HAMAMELIS VIRGINIANA LEAFACTIVE MOIETYT07U1161SV6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
LANOLININACTIVE INGREDIENT7EV65EAW6H6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU6
WATERINACTIVE INGREDIENT059QF0KO0R6

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
34666-00734666-007-28, 34666-007-16

Ingredients#

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

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

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

Source Document#

Source XML

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 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica Montana NartexARNICA MONTANA, HAMAMELIS VIRGINICANARTEX LABORATORIOS HOMEOPATICOS SA DE CV3d2355e3-7ab8-4e4b-b811-38f33336212d2018-12-27WarningsExact identifier
ndc (package): 34666-007-16
ndc (package): 34666-007-28
ndc (product): 34666-007
ndc11 (package): 34666000728
ndc11 (package): 34666000716
spl id: 7e0888e7-ea6b-2831-e053-2991aa0a438a
spl set id: 3d2355e3-7ab8-4e4b-b811-38f33336212d

Reported adverse events (FAERS/openFDA)#

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