SPL v1
SPL
SPL Set ID 86431a9a-5b53-c28a-e053-2991aa0a9901
Routes
ORAL TOPICAL
Published
Effective Date 2019-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_C]) Hamamelis Virginiana Leaf (1 [hp_X])
Inactive Ingredients
Lactose, Unspecified Form Starch, Potato Talc Gelatin Magnesium Stearate Water Petrolatum Glycerin Paraffin Sodium Benzoate Lanolin

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Shape: freeform Color: white Size: 10 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-04-11

Description

Arnica Montana 6C HPUS* *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" is an homeopathic dilution. See www.nartexlabsusa.com formore information. 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.

Purpose

Arnica Montana 6C HPUS* .....Anti-inflammatory


Medication Information

Purpose

Arnica Montana 6C HPUS* .....Anti-inflammatory

Description

Arnica Montana 6C HPUS* *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" is an homeopathic dilution. See www.nartexlabsusa.com formore information. 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.

Uses

For the temporary relief of sore muscles, bruises, sprains

Product uses are based on Homeopathic Materia Medica not clinical tests. This product has not been clinically tested by Nartex Labs USA, Inc.

Section 42229-5

Product of Mexico / Producto de Mexico

Distributed by: Nartex Labs, USA, Inc.

11711 Memorial Drive #685 Houston, TX 77024

www.nartexlabsusa.com

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 das 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 50569-3

Stop use and ask a physcian if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops.
Section 53414-9

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

Warnings

Do not use if you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.

Directions
  • Adults and children 4 yers of age and older: take 2 tablets every 6 hours, slowly dissolving in the mouth
  • Children under 4 years of age: consult a physician
Other Information

Store in a cool and dry place.

Active Ingredients

Each does contains equial parts of:

Anrica Montana TINC HPUS*

Hamamelis virginiana TINC HPUS*

Inactive Ingredients

Gelatin, Lactose, Magnesium stearate, Potato stach, Talc

Questions Or Comments?

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

Principal Display Panel

HOMEOPATHIC

Arnica Nartex

for sore muscles and bruises

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

COMBO PACK

There is no scientific evidence that the product works. Product's claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Contains

1 tube Net. Wt. 1.05oz (29.7g) and 1 Box 60 tablets

Active Ingredient (in Each Tablet)

Arnica Montana 6C HPUS*

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


Structured Label Content

Uses

For the temporary relief of sore muscles, bruises, sprains

Product uses are based on Homeopathic Materia Medica not clinical tests. This product has not been clinically tested by Nartex Labs USA, Inc.

Section 42229-5 (42229-5)

Product of Mexico / Producto de Mexico

Distributed by: Nartex Labs, USA, Inc.

11711 Memorial Drive #685 Houston, TX 77024

www.nartexlabsusa.com

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 das 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 50569-3 (50569-3)

Stop use and ask a physcian if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops.
Section 53414-9 (53414-9)

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

Purpose

Arnica Montana 6C HPUS* .....Anti-inflammatory

Warnings

Do not use if you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.

Directions
  • Adults and children 4 yers of age and older: take 2 tablets every 6 hours, slowly dissolving in the mouth
  • Children under 4 years of age: consult a physician
Other Information

Store in a cool and dry place.

Active Ingredients

Each does contains equial parts of:

Anrica Montana TINC HPUS*

Hamamelis virginiana TINC HPUS*

Inactive Ingredients

Gelatin, Lactose, Magnesium stearate, Potato stach, Talc

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

HOMEOPATHIC

Arnica Nartex

for sore muscles and bruises

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

COMBO PACK

There is no scientific evidence that the product works. Product's claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Contains

1 tube Net. Wt. 1.05oz (29.7g) and 1 Box 60 tablets

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Arnica Montana 6C HPUS*

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


Advanced Ingredient Data


Raw Label Data

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