Arnica Montana Pellet
FDA Label NDC 34666-091

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nartex Laboratorios Homeopaticos Sa De Cv for the product Arnica Montana (NDC 34666-091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Arnica montana......6C HPUS

Otc - Purpose

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 is a homeopathic dilution. See www.nartexlabsusa.com for more information. Active ingredients are preparaed in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Indications & Usage

For the temporary relief of:

  • sore muscles
  • bruises
  • sprains

    • as per homeopathic materia medica

    Product uses are based on Homeopathic Materia Medica.  These "Uses" have not been evaluated by the Food and Drug Adminsitration.  This product has not been clinically tested by Nartex Labs USA, Inc.

Warnings

Do not use if you have an allergy or hypersensitivity to the components of the formula.

Otc - Stop Use

Stop use and ask a physician if:

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, consult a health professional.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

  • adults and children over 4 years of age: take 3 pellets orally every 6 hours
  • children under 4 years of age: consult a physician
  • dissolve slowly in mouth

Storage And Handling

Store in a cool and dry place

Inactive Ingredient

Sucrose

Otc - Questions

Questions or comments?[email protected] or call 1-877-248-1970 between 9am and 5pm CST

Description

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

Keep carton.  It contains important information.

For you protection, this bottle has a seal around the neck.  Attention: do not use if the neck seal is broken. 

This product is HOMEOPATHIC. Its claims and efficacy are based on homeopathic research and clinical experience. This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs. For more information on homeopathiy visit www.nartexlabsusa.com before using this product.

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

Package Label.Principal Display Panel

NDC 34666-091-50

Arnica

Nartex

Pellets

For Sore muscles and bruises*

Homepthatic

*Based on Homeopathic Materia Medica

Arnica

Nartex

Directions

3 pellets orally every 6 hours**

**See Directions at the Back

150 pellets

Arnicapelletcarton (Arnicapelletscarton)

Arnicapelletcarton (Arnicapelletscarton)

* Please review the disclaimer below.