Arnica Treatment Pack

Manufacturer
Nartex Laboratorios Homeopaticos SA DE CV
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:16

Label at a glance#

ProductArnica Treatment Pack
Active ingredientARNICA MONTANA, HAMAMELIS VIRGINIANA LEAF
Label structure26 sections

Indications and uses

For the temporary relief of sore muscles, bruises, sprains Product uses are based on Homeopathic Materia Medica not clinical tests. This product has not been clinically tested by Nartex Labs USA, Inc.

Dosage and administration

Adults and children 4 yers of age and older: take 2 tablets every 6 hours, slowly dissolving in the mouth Children under 4 years of age: consult a physician

Storage and handling

Store in a cool and dry place.

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 6C HPUS*

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

Purpose

OTC - PURPOSE SECTION

Arnica Montana 6C HPUS* .....Anti-inflammatory

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of sore muscles, bruises, sprains

Product uses are based on Homeopathic Materia Medica not clinical tests. This product has not been clinically tested by Nartex Labs USA, Inc.

Warnings

WARNINGS SECTION

Do not use if you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.

OTC - ASK DOCTOR SECTION

Stop use and ask a physcian if

  • condition worsens
  • 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 breastfeeding, 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 4 yers of age and older: take 2 tablets every 6 hours, slowly dissolving in the mouth
  • Children under 4 years of age: consult a physician

Other Information

STORAGE AND HANDLING SECTION

Store in a cool and dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Gelatin, Lactose, Magnesium stearate, Potato stach, Talc

Questions or Comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Product of Mexico / Producto de Mexico

Distributed by: Nartex Labs, USA, Inc.

11711 Memorial Drive #685 Houston, TX 77024

www.nartexlabsusa.com

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each does contains equial parts of:

Anrica Montana TINC HPUS*

Hamamelis virginiana TINC HPUS*

Purpose

OTC - PURPOSE SECTION

Arnica Montana TINC HPUS*.......Anti-inflammatory/Pain Relief

Hamamelis virginiana TINC HPUS.....Anti-inflammatory/Pain Relief

Uses

INSTRUCTIONS FOR USE SECTION

Temporary relief for the symptoms of sore muscles, bruises, and sprains. Product uses are based on Homeopathic Materia Medica not clinical tests.

Warnings

WARNINGS SECTION

For external use only.

Do not

  • Apply to wounds tor 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 das 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 physcian

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Lanolin, 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.

SPL UNCLASSIFIED SECTION

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

There is no scientific evidence that the product works. Product's claims are baed only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Montana KitArnica Montana KitHOMEOPATHIC

Arnica Nartex

for sore muscles and bruises

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

COMBO PACK

There is no scientific evidence that the product works. Product's claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Contains

1 tube Net. Wt. 1.05oz (29.7g) and 1 Box 60 tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-020-01Arnica Treatment Pack1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-020ARNICA TREATMENT PACK KIT [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]1Current NDC, Legacy NDC, 1 package rows20190412_86431a9a-5b53-c28a-e053-2991aa0a9901.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-02034666-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 Treatment PackARNICA TREATMENT PACKNartex Laboratorios Homeopaticos SA DE CV86431a9a-5b53-c28a-e053-2991aa0a99012019-04-11WarningsExact identifier
ndc (package): 34666-020-01
ndc (product): 34666-020
ndc11 (package): 34666002001
spl id: 86431a9a-5b54-c28a-e053-2991aa0a9901
spl set id: 86431a9a-5b53-c28a-e053-2991aa0a9901

Reported adverse events (FAERS/openFDA)#

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