Label: ARTHRONEW AM- not applicable gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated November 6, 2014

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)