ARNICA ACTIVE MONTANA NARTEX- arnica montana, hamamelis virginiana gel

Arnica Active Montana Nartex by

Drug Labeling and Warnings

Arnica Active Montana Nartex by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Each dose contains equal parts of:

Arnica montana TINC HPUS*

Hamamelis virginia TINC HPUS*

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

Purpose

Each dose contains equal parts of:

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

Hamamelis virginia TINC HPUS*.........................Anti-inflammatory/Pain relief

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

Uses

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

Claims based on traditional homeopathic practice, not accepted medical evidence. The uses have not been evaluated by FDA, and product has not been clinically tested.

Warnings

For external use only.

Warnings

Do not

• apply to wounds or damaged skin
• apply over large areas of the body

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

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

If pregnant or breast feeding, consult a health professional before use.

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

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

• do not use if the tube seal is broken or missing
• store at room temperature

Inactive ingredients

Alcohol, Carbomer, Menthol (fragrance), Purified water, Sodium hydroxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

New

NDC: 34666-407-01

Arnica Active Montana Nartex

Gel

Homeopathic temporary relief for the symptoms of Sore Muscles, Bruises and Sprains.

Arnica & Hamamelis

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

Paraben Free

Non-Greasy

With menthol as fragrance

Homeopathic

Absorbs quickly

For external use only

contains Witch Hazel

Hamamelis

Net Wt. 2.6 oz (74 g)

INGREDIENTS AND APPEARANCE

ARNICA ACTIVE MONTANA NARTEX 
arnica montana, hamamelis virginiana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-407
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 74 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 74 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
MENTHOL (UNII: L7T10EIP3A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-407-01	1 in 1 CARTON	12/30/2021
1		74 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/30/2021

Labeler - Nartex Laboratorios Homeopaticos, S.A. de C.V. (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos, S.A. de C.V.		589914576	manufacture(34666-407)