Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID d1407fcf-ae2e-4dac-95bf-6a5f0b21f3a6
Route
TOPICAL
Published
Effective Date 2013-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1.73 g) Hamamelis Virginiana Leaf (0.0178 g)
Inactive Ingredients
Petrolatum Lanolin Glycerin Paraffin Sodium Benzoate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-06-01

Description

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


Medication Information

Purpose

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



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

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


Uses:

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

Do Not
  • apply to wounds or damaged skin
  • apply over large areas of the body

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 60561-8

If swallowed, get medical help or contact a Poison Control Center right away.

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

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.

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




Questions Or Comments?

[email protected] or call 1-800-838-0916 between 9am and 5pm CST

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)





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


Structured Label Content

Uses:

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

Do Not (Do not)
  • apply to wounds or damaged skin
  • apply over large areas of the body

Description (34089-3)
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


Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

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



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

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 (Other information)
  •  store at room temperature

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.

Inactive Ingredients (Inactive ingredients)
Glycerin, Lanolin wax, Paraffin wax, Sodium benzoate, Water, White petrolatum




Questions Or Comments? (Questions or comments?)

[email protected] or call 1-800-838-0916 between 9am and 5pm CST

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)





When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If (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


Advanced Ingredient Data


Raw Label Data

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