ARTHRONEW PM- 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:

ARNICA MONTANA 6X, 12X,  HAMAMELIS VIRGINIANA 6X, 12X,  RHUS TOXICODENDRON 6X, 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 evening. 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, DEVIL'S CLAW (ROOT), EDETATE DISODIUM (EDTA), MIXED TOCOPHEROLS [VITAMIN E] (DERIVED FROM SOY BEAN), NATURAL PLANT EXTRACT, PEG-33, PEG-8 DIMETHICONE, PEG-14, PEPPERMINT (LEAF), PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID, POTASSIUM SORBATE, PURIFIED WATER, SODIUM HYDROXIDE, WHITE WILLOW (BARK), WITCH HAZEL (BARK)

QUESTIONS:

Dist. By

PureCore Wellness, Inc.

Austin, TX 78733

800-448-7442

www.ArthroNewProducts.com

PACKAGE LABEL DISPLAY:

ARTHRONEW

PM

HOMEOPATHIC

JOINT RELIEF

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

ARTHRONEW  PM
not applicable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61045-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [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)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SALIX ALBA BARK (UNII: 205MXS71H7)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61045-0002-1	57 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(61045-0002) , api manufacture(61045-0002) , label(61045-0002) , pack(61045-0002)