OUTPAIN- acontium napellus, apis mellifica, arnica, bryonia, calendula officinalis, camphora, hamamelis, phytolacca, rhus toxicodendron, symphitum cream

Outpain by

Drug Labeling and Warnings

Outpain 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]

Active Ingredients

Each dose contains equal parts of:

Aconitum napellus​   ​​TINC HPUS

​Apis mellifica   86X HPUS

​Arnica​   TINC HPUS

​Bryonia​​   4X HPUS

​Calendula officinalis​   1X HPUS

​Camphora​   3X HPUS

​Hamamelis​   TINC HPUS

​Phytolacca​   6X HPUS

​Rhus toxicodendron​   6X HPUS

​Symphitum​   6X HPUS

Purpose

Each dose contains equal parts of:

Aconitum napellus TINC HPUS*..........Anti-inflammatory

Apis mellifica 86X HPUS*....................Localized swelling

Arnica TINC HPUS*.............................Anti-inflammatory

Bryonia 4X HPUS*..............................Acute localized pain

Calendula officinalis 1X HPUS*...........Pain relief

Camphora 3X HPUS*..........................Relieves muscle pain

Hamamelis TINC HPUS*......................Anti-inflammatory

Phytolacca 6X HPUS*..........................Relieves muscle pain

Rhus toxicodendron 6X HPUS*...........Anti-inflammatory

Symphitum 6X HPUS*.........................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 is an homepoathic dilution.  See www.nartexlabsusa.com for more information.

Uses

 For temporary relief of:

• bumps
• bruises
• sprains

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

Warnings

​For external use only.

​Do not​

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

​When using this product​

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

​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

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

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

Directions

• Adults and children over 4 year of age: apply a light coat in the affected area every 7 hours

​Other information

• store at room temperature
• do not use if the safety seal of container is broken or missing

​Inactive ingredients

Carbomer, glycerin, propylene glycol, propylparaben sodium, sodium methylparaben, triethanolamine, water

​Questions or comments?

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

DESCRIPTION

Outpin

Arnica

Montana Nartex

10 natural active ingredients

For athletes

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

DESCRIPTION

Keep carton.  It contains important information.

Product of Mexico

Distributed by: Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

PRINCIPAL DISPLAY PANEL

GEL

NDC: 34666-271-65

Arnica Montana Nartex

10 natural active ingredients

FOR ATHLETES

Outpain

For temporary relief of sports injury

symptoms such as: Bumps, Bruises, and Sprains

There is no scientific evidence that hte product works.

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

Directions

Adults and children over 4 years of age: apply a light coat in the affected area every 7 hours*

*​See directions at the back​

Homeopathic

Net Wt 2.29 oz (65g)

INGREDIENTS AND APPEARANCE

OUTPAIN 
acontium napellus, apis mellifica, arnica, bryonia, calendula officinalis, camphora, hamamelis, phytolacca, rhus toxicodendron, symphitum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	0.0123 g  in 65 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	8 [hp_X]  in 65 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	0.0123 g  in 65 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]  in 65 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 65 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3 [hp_X]  in 65 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	0.0123 g  in 65 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_X]  in 65 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]  in 65 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 65 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-271-65	1 in 1 CARTON	05/15/2017
1		65 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/15/2017

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(34666-271)