Arnica Montana - Roll On

Arnica Montana - Roll On
SPL v1
SPL
SPL Set ID 86567f91-7792-1094-e053-2991aa0a4a0b
Route
TOPICAL
Published
Effective Date 2019-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X]) Bellis Perennis (3 [hp_X]) Calendula Officinalis Whole Matricaria Chamomilla Hamamelis Virginiana Whole
Inactive Ingredients
Anhydrous Citric Acid Glycerin Water Aloe Vera Leaf Menthol Methylparaben Sodium Propylparaben Sodium Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-25

Description

Arnica TINC HPUS* Bellis 3X HPUS* Calendula HPUS* Chamomila 3X HPUS* Hamamelis 3x HPUS*

Purpose

Arnica TINC HPUS*...............Anti-inflammatory/Pain Relief Bellis 3X HPUS*.....................Sprains and Bruises Calendula HPUS*..................Pain Relief Chamomila 3X HPUS*..........Anti-inflammatory Hamamelis 3x 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 and X are homeopathic dilutions. See www.nartexlabsusa.com for more information.


Medication Information

Purpose

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

Bellis 3X HPUS*.....................Sprains and Bruises

Calendula HPUS*..................Pain Relief

Chamomila 3X HPUS*..........Anti-inflammatory

Hamamelis 3x 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 and X are homeopathic dilutions. See www.nartexlabsusa.com for more information.

Description

Arnica TINC HPUS* Bellis 3X HPUS* Calendula HPUS* Chamomila 3X HPUS* Hamamelis 3x HPUS*

Uses

For the temporary relief of:

  • sore muscles
  • bruises
  • sprains
  • minor burns
  • insect bites

Indications are based on homeopathic materia medica, not clnical tests.

Section 42229-5

There is no scientific evidence that the product works.

Product's claims are based only on theories of homepathy from the 1700's that are not accepted by most modern medical experts.

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and have no known side effects.

Product of Mexico / Producto de Mexico

Distributed by:

Nartex Labs USA, inc

11711 Memorial Dr. # 685

Houston TX, 77024

www.nartexlabsusa.com

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if:

  • symptoms persis 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 or use with a heating pad
Section 50570-1

Do not:

  • apply to open wounds
  • apply over large areas of the body
Section 51945-4

HOMEOPATHIC

ARNICA

MONTANA NARTEX

ROLL-ON GEL

For the temporary relief of:

sore muscles, bruises, sprains, minor burns and insect bites.

Net Wt. 2.11 oz (60 g)

Section 53414-9

If pregnant or breastfeeding, consult a health professional before use.

Warnings

For External Use only

Directions

Adults and Children over 4 years of age: apply and gently massage the affected area every 4 hours.

Other Information
  • Store at room temperature
  • Do not use if the safety seal of container is broken or missing.
Active Ingredients

Arnica TINC HPUS*

Bellis 3X HPUS*

Calendula HPUS*

Chamomila 3X HPUS*

Hamamelis 3x HPUS*

Inactive Ingredients

Aler Vera (Aloe barbadensis Miller) leaf powder, citric acid, glycerin, menthol, methylparaben sodium, propylene glycol, propylparaben sodium, purified water, xanthan gum

Questions Or Comments?

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


Structured Label Content

Uses

For the temporary relief of:

  • sore muscles
  • bruises
  • sprains
  • minor burns
  • insect bites

Indications are based on homeopathic materia medica, not clnical tests.

Section 42229-5 (42229-5)

There is no scientific evidence that the product works.

Product's claims are based only on theories of homepathy from the 1700's that are not accepted by most modern medical experts.

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and have no known side effects.

Product of Mexico / Producto de Mexico

Distributed by:

Nartex Labs USA, inc

11711 Memorial Dr. # 685

Houston TX, 77024

www.nartexlabsusa.com

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if:

  • symptoms persis 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 or use with a heating pad
Section 50570-1 (50570-1)

Do not:

  • apply to open wounds
  • apply over large areas of the body
Section 51945-4 (51945-4)

HOMEOPATHIC

ARNICA

MONTANA NARTEX

ROLL-ON GEL

For the temporary relief of:

sore muscles, bruises, sprains, minor burns and insect bites.

Net Wt. 2.11 oz (60 g)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, consult a health professional before use.

Purpose

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

Bellis 3X HPUS*.....................Sprains and Bruises

Calendula HPUS*..................Pain Relief

Chamomila 3X HPUS*..........Anti-inflammatory

Hamamelis 3x 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 and X are homeopathic dilutions. See www.nartexlabsusa.com for more information.

Warnings

For External Use only

Directions

Adults and Children over 4 years of age: apply and gently massage the affected area every 4 hours.

Other Information
  • Store at room temperature
  • Do not use if the safety seal of container is broken or missing.
Active Ingredients

Arnica TINC HPUS*

Bellis 3X HPUS*

Calendula HPUS*

Chamomila 3X HPUS*

Hamamelis 3x HPUS*

Inactive Ingredients

Aler Vera (Aloe barbadensis Miller) leaf powder, citric acid, glycerin, menthol, methylparaben sodium, propylene glycol, propylparaben sodium, purified water, xanthan gum

Questions Or Comments? (Questions or Comments?)

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


Advanced Ingredient Data


Raw Label Data

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