Label: CUROXEN PAIN RELIEF- olive extract, calendula, arnica montana ointment

  • NDC Code(s): 71042-002-14
  • Packager: OrganiCare Nature's Science, LLC
  • 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 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Homeopathic Ingredients

    Arnica Montana 3X HPUS

    Calendula 3X HPUS

    Olive Extract 2X HPUS

  • PURPOSE

    Purpose

    Pain Reliever

    Healing Agent

    Antimicrobial and Healing Agent

  • INDICATIONS & USAGE

    Use

    first aid to help prevent infection, promote healing, and relieve pain in minor:

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • condition persists or gets worse
    • rash or other allergic reaction develops
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area
    • apply a thin layer of Curoxen to the affected area 3 times a day or as needed
    • may be covered with a sterile bandage
  • STORAGE AND HANDLING

    Other information

    • store at 68° to 77°F (20° to 25°C)
    • if liquefied, refrigerate 10 minutes to thicken
  • INACTIVE INGREDIENT

    Inactive ingredients

    oxygenated olive oil, pure essential oil (lavender)

  • QUESTIONS

    Questions?

    Call 512-814-0038 or

    Visit www.curoxen.com

  • SPL UNCLASSIFIED SECTION

    Distributed by

    OrganiCare®

    Austin, TX 78744

    Made in Italy

  • PRINCIPAL DISPLAY PANEL

    CUROXEN®

    WITH ARNICA FOR PAIN RELIEF

    FIRST AID OINTMENT

    A Homeopathic Medicine that helps prevent Infection in minor cuts, scrapes, and burns

    NET WT 0.5 oz (14.2 g)

    Curoxen Pain Relief

  • INGREDIENTS AND APPEARANCE
    CUROXEN PAIN RELIEF 
    olive extract, calendula, arnica montana ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 14 g
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J) OLEA EUROPAEA FRUIT VOLATILE OIL2 [hp_X]  in 14 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-002-141 in 1 CARTON01/24/2017
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/24/2017
    Labeler - OrganiCare Nature's Science, LLC (044204745)
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