Label: CUROXEN COLD SORE DAY ointment

  • NDC Code(s): 71042-014-14
  • 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 December 12, 2024

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  • Active Ingredients

    Active ingredients Purpose
    CUROXEN Day:
    Arnica 3X HPUS..............................................Pain reliever
    Lemon Balm 2X HPUS ....................................Antiviral agent
    Olive Extract (Oleuropein) 3X HPUS ...............Healing agent
    CUROXEN Night:
    Lemon Balm 2X HPUS ....................................Antiviral agent
    Olive Extract (Oleuropein) 3X HPUS ...............Healing agent

  • Ask a doctor

    Stop use and ask a doctor  your cold sore gets worse or
    the cold sore is not healed within 10 days

  • Do Not Use

    Do not use
     if you are allergic to any ingredient in this product

  • Keep out of the reach of children.

    Keep out of the reach of children. If swallowed, get
    medical help or contact a Poison Control Center right away.

  • Uses

    Uses
    This product is intended to relieve symptoms
    associated with cold sores or fever blisters, including:
    · tingling, pain, burning, and/or itching

  • Questions

    Questions?
    Call 512.401.3572 or visit curoxen.com
    Made and Distributed by OrganiCare, LLC
    Austin, TX 78744, USA

  • Stop use and ask a doctor

    Stop use and ask a doctor  your cold sore gets worse or
    the cold sore is not healed within 10 days

  • Directions

    Directions
     Adults and children 12 years or over:
     best used at the first sign of a cold sore. Early use
    ensures best results
     wash hands before and after applying the ointment
     apply to affected area on face or lips
    CUROXEN Day:
     use at minimum 4 times daily and then as needed
     apply generously to the affected area
    CUROXEN Night:
     apply liberally before bedtime
     Children under 12 years: ask a doctor

  • When Using this Product

    When using this product
     consult a healthcare professional before using this
    product if this is the first time you have a cold sore or fever
    blister
     apply only to the affected areas
     do not use in or near the eyes
     do not share this product with anyone. This may spread
    the infection/virus

  • Inactive Ingredients

    Inactive ingredients
    CUROXEN Day: beeswax, lysine, essential oil (natural
    fragrance), oxygenated olive oil
    CUROXEN Night: beeswax, jojoba oil, lysine, essential oil
    (natural fragrance), oxygenated olive oil

  • Other Information

    Other information
     Store at 68 – 77° F (20° C – 25° C)
     If liquefied, refrigerate 10 minutes to thicken

  • Warnings

    Warnings
    For external use only
    There is no known cure for the cold sore virus, including
    CUROXEN. Nothing will prevent future outbreaks. This
    product will not stop the spread of viruses. Viral infections
    are contagious.

  • PRINCIPAL DISPLAY PANEL

    Cold Sore Day Night

  • INGREDIENTS AND APPEARANCE
    CUROXEN COLD SORE DAY 
    curoxen cold sore day ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEMON BALM OIL (UNII: MJ76269K9S) (LEMON BALM OIL - UNII:MJ76269K9S) LEMON BALM OIL1 g  in 100 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E) 94.8 g  in 100 g
    VETIVER OIL (UNII: 9M9P32M01L) 2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-014-141 in 1 CARTON12/02/2021
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/02/2021
    Labeler - OrganiCare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrganiCare Nature's Science, LLC044204745manufacture(71042-014)
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