Arnica Montana Nartex Cream
FDA Label NDC 34666-001

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 Nartex (NDC 34666-001). 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 active ingredients, purpose, uses:, warnings, do not, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

Arnica montana TINC HPUS......................Anti-inflammatory/Pain relief

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

Uses:

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

Warnings

For external use only.

Directions

  • 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

  •  store at room temperature

Inactive Ingredients

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


Description

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

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 Carton (Arnica2013label)

Arnical 2012 Carton (Arnica2013label)

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