SPL v1
SPL
SPL Set ID d63b84e1-24c1-6c6c-e053-2995a90a22ce
Route
TOPICAL
Published
Effective Date 2022-01-21
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 2022-01-21

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 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 virginiana 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.


Medication Information

Purpose

Each dose contains equal parts of:

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

Hamamelis virginiana 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.

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 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. These uses have not been evaluated by FDA, and product has not been clinically tested.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product

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

Section 50570-1

Do not

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

Section 53414-9

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

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
  • do not use if tube seal is broken or missing

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.

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

Questions Or Comments?

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

Principal Display Panel

NDC 34666-001-30

Arnica Montana Nartex Cream

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

Arnica & Hamamelis

For external use only

Paraben free

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

Homeopathic

Net Wt. 2.6oz (74 g)


Structured Label Content

Uses

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

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

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

Section 50570-1 (50570-1)

Do not

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

Section 53414-9 (53414-9)

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

Purpose

Each dose contains equal parts of:

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

Hamamelis virginiana 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.

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
  • do not use if tube seal is broken or missing

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.

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

NDC 34666-001-30

Arnica Montana Nartex Cream

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

Arnica & Hamamelis

For external use only

Paraben free

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

Homeopathic

Net Wt. 2.6oz (74 g)


Advanced Ingredient Data


Raw Label Data

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