Label: CUROXEN- olive extract, calendula ointment

  • NDC Code(s): 71042-001-01, 71042-001-14, 71042-001-28
  • 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

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Homeopathic Ingredients

    Olive Extract 2X HPUS

    Calendula 3X HPUS

  • PURPOSE

    Purpose

    Antimicrobial Healing Agent

    Healing Agent

  • INDICATIONS & USAGE

    Use

    first aid to help prevent infection and promote healing 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

  • SPL UNCLASSIFIED SECTION

    When we were kids, a sympathetic hug from mom and a dab of antibiotic ointment is how we treated minor cuts, scrapes, and burns. We still appreciate a hug, but treating wounds with most products on the market today means exposure to synthetic antiobiotics, which don't kill bacteria very well.

    Introducing CUROXEN, an all-natural, organic first aid ointment, proven* to be over 5x more effective at killing bacteria than any other natural or synthetic product on the market. Its power and protection come from oxygened olive oil. Strong, safe, smart.

    [CHART]

    Why hasn't anyone thought of this before? Actually they have. CUROXEN is made in Italy. Combining technological advances with the deep history and heritage of homeopathy that Europeans are noted for, CUROXEN may become the next must-have Italian import.

    We believe in hugs, but now we have something more effective to treat minor wounds. Reach for the better choice first when you have a minor cut, scrape, or burn: CUROXEN.

    * In vitro bacteria log reduction testing was performed according to ASTM E2315, and FDA-recognized standard, by Nelson Laboratories, a certified, independent laboratory. Bacteria levels were measured after one hour of contact with the product. The chart shows the average amount of bacteria killed for five common bacteria species: MRSA, S. Aureus, P. Aeroginosa, E. Coli and E. Faecalis.

    Curoxen_Sample_Insert

  • PRINCIPAL DISPLAY PANEL

    CUROXEN®
    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 Final Carton

  • PRINCIPAL DISPLAY PANEL

    CUROXEN®

    ALL NATURAL AND ORGANIC FIRST AID OINTMENT

    5X STRONGER At Killing Germs

    Distributed By:

    OrganiCare

    Austin, TX 78744

    Made in Italy

    NET WT 0.04 oz (1.0 g)

    Homeopathic medicine that helps prevent infection in minor cuts, scrapes, and burns

    Curoxen_Sample_PDP

  • INGREDIENTS AND APPEARANCE
    CUROXEN 
    olive extract, calendula ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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:71042-001-141 in 1 CARTON10/21/2016
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71042-001-011 in 1 BLISTER PACK01/19/2017
    21 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:71042-001-281 in 1 CARTON12/20/2017
    328.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/21/2016
    Labeler - OrganiCare Nature's Science, LLC (044204745)