ARTHRONEW AM- not applicable gel 
PureCore Wellness, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

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)

ARTHRONEW AM

ARTHRONEW  AM
not applicable gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61045-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 g
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]  in 1 g
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB12 [hp_X]  in 1 g
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF12 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61045-0001-185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/03/2014
Labeler - PureCore Wellness, Inc. (079158894)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(61045-0001) , api manufacture(61045-0001) , label(61045-0001) , pack(61045-0001)

Revised: 11/2014
Document Id: 753319dd-5c98-4d20-869a-47624b4be42d
Set id: 6c625f9a-cb9c-4e44-9546-49924039dbfe
Version: 2
Effective Time: 20141106
 
PureCore Wellness, Inc.