MedPath

Arnica Montana

Approved
Approval ID

3c62d081-4178-4ac0-b81f-d97202dee8ea

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

NARTEX LABORATORIOS HOMEOPATICOS SA DE CV

DUNS: 589914576

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Arnica Montana

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code34666-091
Product Classification
G
Generic Name
Arnica Montana
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
ARNICA MONTANAActive
Quantity: 6 [hp_C] in 1 1
Code: O80TY208ZW
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

NDC 34666-091-50

Arnica

Nartex

Pellets

For Sore muscles and bruises

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

Homeopathic

150 pellets

1

2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/11/2016

For the temporary relief of:

  • sore muscles
  • bruises
  • 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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/8/2016

Arnica montana......6C HPUS

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/8/2016

Arnica montana.......6C HPUS*......anti-inflammatory

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

WARNINGS SECTION

LOINC: 34071-1Updated: 3/8/2016

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula.
  • more than the maximum daily dosage unless directed by a doctor.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/11/2016

Stop use and ask a doctor if:

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 3/8/2016

If pregnant or breast feeding, consult a health professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 3/8/2016

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/8/2016

Directions

  • Allow pellets to dissolve slowly in the mouth.
  • Adults and children over 4 years of age: take 3 pellets orally every 6 hours.
  • Children under 4 years of age: consult a doctor.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/8/2016
  • Store at room temperature.
  • Do not use if container seal is broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/8/2016

Sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/8/2016

Questions or comments?informacion@nartexlabs.comor call 1-877-248-1970 between 9am and 5pm CST

DESCRIPTION SECTION

LOINC: 34089-3Updated: 3/8/2016

Distributed by:

Nartex Labs USA, Inc.

9543 Bissonnet St. Ste. 302

Houston TX 77036 USA

www.nartexlabsusa.com

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Arnica Montana - FDA Drug Approval Details