ARTHRONEW AM- not applicable gel

ARTHRONEW by

Drug Labeling and Warnings

ARTHRONEW by is a Homeopathic medication manufactured, distributed, or labeled by PureCore Wellness, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

SYMPHYTUM OFFICINALE 3X,  CAPSICUM ANNUUM 6X,  LEDUM PALUSTRE 6X,  COLCHICUM AUTUMNALE 12X,  RHODODENDRON CHRYSANTHUM 12X,  RUTA GRAVEOLENS 12X

INDICATIONS:

For temporary relief of minor symptoms of joint pain and inflammation.

WARNINGS:

For external use only. If pregnant or breastfeeding, ask a health professional before use.

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

When using this product - Do not get into eyes. Stop use and consult a doctor if condition worsens.

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:

Apply over the affected area once in the morning. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of minor symptoms of joint pain and inflammation.

INACTIVE INGREDIENTS:

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, ARNICA (FLOWER), ASCORBIC ACID, CELERY (SEED), COMFREY (LEAF), DEVIL'S CLAW (ROOT), EDETATE DISODIUM (EDTA), FEVERFEW (LEAF), MIXED TOCOPHEROLS [VITAMIN E] (DERIVED FROM SOY BEAN), NATURAL PLANT EXTRACT, PEG-33, PEG-8 DIMETHICONE, PEG-14, PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID, POKE (ROOT), POTASSIUM SORBATE, PURIFIED WATER, SODIUM HYDROXIDE, TURMERIC (ROOT), WHITE WILLOW (BARK)

QUESTIONS:

Dist. By

PureCore Wellness, Inc.

Austin, TX 78733

800-448-7442

www.ArthroNewProducts.com

PACKAGE LABEL DISPLAY:

ARTHRONEW

AM

HOMEOPATHIC

JOINT RELIEF

Net wt. 3 oz. (85 g)

INGREDIENTS AND APPEARANCE

ARTHRONEW  AM
not applicable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61045-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 1 g
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 1 g
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	12 [hp_X]  in 1 g
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	12 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CELERY SEED (UNII: 1G1EAA320L)
COMFREY LEAF (UNII: DG4F8T839X)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FEVERFEW (UNII: Z64FK7P217)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TURMERIC (UNII: 856YO1Z64F)
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61045-0001-1	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/03/2014

Labeler - PureCore Wellness, Inc. (079158894)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(61045-0001) , api manufacture(61045-0001) , label(61045-0001) , pack(61045-0001)