Arnica WH MONTANA NARTEX by Nartex Laboratorios Homeopaticos, S.A. de C.V. Arnica WH MONTANA NARTEX

Drug Details [pdf]

ARNICA WH MONTANA NARTEX- arnica montana, hamamelis virginiana gel
Nartex Laboratorios Homeopaticos, S.A. de C.V.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Arnica WH MONTANA NARTEX

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 United States. TINC is an homeopathic dilution. See www.nartexlabsusa.com for more information.

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.

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.

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

New

NDC: 34666-401-01

Arnica WH

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)

ARNICA WH MONTANA NARTEX
arnica montana, hamamelis virginiana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-401
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X] in 1 g
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU)	HAMAMELIS VIRGINIANA WHOLE	1 [hp_X] in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 34666-401-01	1 in 1 CARTON	05/19/2021	11/19/2024
1		74 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/19/2021	11/19/2024

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

Name	Address	ID/FEI	Business Operations
Establishment
Nartex Laboratorios Homeopaticos, S.A. de C.V.		589914576	manufacture(34666-401)

Revised: 12/2024

Document Id: 291886ce-730a-343b-e063-6394a90a888c

Set id: c1708f58-3f1d-449f-e053-2a95a90aa4d4

Version: 2

Effective Time: 20241212

Nartex