ARNICA TREATMENT PACK kit

Arnica Treatment Pack by

Drug Labeling and Warnings

Arnica Treatment Pack by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Arnica Treatment Pack - Arnica Recovery Tablets

Drug Facts

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.

Purpose

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

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.

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.

ASK DOCTOR

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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.

Inactive Ingredients

Gelatin, Lactose, Magnesium stearate, Potato stach, Talc

Questions or Comments?

Informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST.

SPL UNCLASSIFIED SECTION

Product of Mexico / Producto de Mexico

Distributed by: Nartex Labs, USA, Inc.

11711 Memorial Drive #685 Houston, TX 77024

www.nartexlabsusa.com

Arnica Treatment Pack - Arnica Recovery Cream

Drug Facts

Active Ingredients

Each does contains equial parts of:

Anrica Montana TINC HPUS*

Hamamelis virginiana TINC HPUS*

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. Product uses are based on Homeopathic Materia Medica not clinical tests.

Warnings

For external use only.

Do not

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

WHEN USING

When using this product

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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 physcian

Other Information

Store at room temperature

Inactive Ingredients

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

Questions or Comments?

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST.

SPL UNCLASSIFIED SECTION

Active Ingredients are prepared in accordance with the Homeopathic Pharmaocopoeia of the United States, and are therefore non-toxic and have no known side effects.

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

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

INGREDIENTS AND APPEARANCE

ARNICA TREATMENT PACK 
arnica treatment pack kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-020

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-020-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	04/11/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	60 BOX	60
Part 2		2   in 2

Part 1 of 2

ARNICA RECOVERY 
arnica recovery tablets tablet

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white)	Score	score with uneven pieces
Shape	ROUND ((tablet))	Size	10mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Part 2 of 2

ARNICA RECOVERY 
arnica recovery cream cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV)	HAMAMELIS VIRGINIANA LEAF	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LANOLIN (UNII: 7EV65EAW6H)

Product Characteristics
Color	white	Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos SA DE CV		589914576	manufacture(34666-020)