Label: THERAGOLD- arnica montana, melissa officinalis seed oil, calendula officinalis flower, capsicum cream

  • 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 May 1, 2018

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  • Active Ingredients

    Arnica (Montana) Extract 3x

    Lemon Balm (Melissa Officinalis) Extract 3x

    Calendula (Calendula Officinalis) Extract 3x

    Caynne Extract (Capsicum Annuum) 3x

  • Purpose

    Pain relief reduces bruising and inflammation

    Anti-inflammatory

    Reduces swelling and redness; increases blood flow to inflamed area

    Anti-inflammatory and directive properties

  • Uses

    Relaxes the muscle and reduces inflammation to alleviate pain while increasing blood flow to calm painful nerve endings.

  • Directions

    Apply to area of inflammation and rub in well. Apply 3-4 times daily.

  • Other Information

    Store at 70°F or below.

  • Inactive Ingredients

    Water, Stearyl Alcohol, Manuka Honey, Peppermint, Ginger Root, Clary Sage, Cetyl Alcohol, Sodium Stearyl Glutamate, Potassium Sorbate, Sodium Benzoate, Glyceryl Monostearate, Decyl Oleate, Coco-caprylate.

  • Warnings

    • For External Use Only

    • Do not use if allergic to bee products
    • Avoid contact with eyes
    • Do not apply to wounds or broken skin
    • Do not bandage tightly
    • Do not apply with external heat, as this may result in excessive skin irritation or skin burn

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
  • Questions or Comments?

    Call 732-820-0707

  • Principal Display Panel - TheraGold Jar Label

    NDC No. 71940-001-50

    HOMEOPATHIC

    theragold

    PAIN RELIEVING RUB

    with Manuka Honey

    10+
    UMF

    NET WT. 2oz. [50g]

    Principal Display Panel - TheraGold Jar Label
  • INGREDIENTS AND APPEARANCE
    THERAGOLD 
    arnica montana, melissa officinalis seed oil, calendula officinalis flower, capsicum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71940-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana3 [hp_X]  in 50 g
    Melissa Officinalis Seed Oil (UNII: MJ76269K9S) (Melissa Officinalis Seed Oil - UNII:MJ76269K9S) Melissa Officinalis Seed Oil3 [hp_X]  in 50 g
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD) (Calendula Officinalis Flower - UNII:P0M7O4Y7YD) Calendula Officinalis Flower3 [hp_X]  in 50 g
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum3 [hp_X]  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Ginger Oil (UNII: SAS9Z1SVUK)  
    Honey (UNII: Y9H1V576FH)  
    Clary Sage Oil (UNII: 87L0D4U3M0)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71940-001-5025 in 1 CARTON05/01/2018
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/01/2018
    Labeler - Square One New Zealand Llc. (080819801)
    Registrant - MaxPax, LLC (017038858)
    Establishment
    NameAddressID/FEIBusiness Operations
    MaxPAx, LLC017038858MANUFACTURE(71940-001)
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