ARNICA MONTANA NARTEX gel

Arnica Montana Nartex by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients

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.

Uses

For the temporary relief of:

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

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

Warnings

For External Use only

DO NOT USE

Do not:

• apply to open wounds
• apply over large areas of the body

WHEN USING

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly or use with a heating pad

STOP USE

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

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

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.

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?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

ARNICA MONTANA NARTEX 
arnica montana nartex gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-281
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]
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	3 [hp_X]
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H)	CALENDULA OFFICINALIS WHOLE	1 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X]
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU)	HAMAMELIS VIRGINIANA WHOLE	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-281-60	1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/25/2019
2	NDC: 34666-281-90	1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/25/2019
3	NDC: 34666-281-30	1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/25/2019

Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratories Homeopaticos SA DE CV		589914576	manufacture(34666-281)