Label: CUROXEN ORAL CARE- olive extract, calendula, clove oil ointment

  • NDC Code(s): 71042-004-12
  • 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 ingredients

    Calendula 3X HPUS

    Clove essential oil 1X

    Olive extract 2X HPUS

  • PURPOSE

    Purposes

    Healing agent

    Oral pain reliever

    Oral antimicrobial and healing agent

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of pain and to help prevent infection and promote healing of:

    • canker sores
    • cold sores
    • fever blisters
    • minor irritation, injury, cuts or other sores of the mouth and gums.
  • WARNINGS

    Warnings

  • STOP USE

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • swelling, rash, fever or other allergic reaction develops
    • irritation, pain or redness persists or worsens
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children of any age, apply to the affected area as needed
    • Children under 12 years of age should be supervised in the use of this product
  • 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 (cinnamon)

  • QUESTIONS

    Questions?

    Call 512-401-3572 or visit www.curoxen.com

  • SPL UNCLASSIFIED SECTION

    Made in Italy

    Distributed by OrganiCare®, Austin, TX 78744

  • PRINCIPAL DISPLAY PANEL

    MADE WITH ORGANIC INGREDIENTS

    NO Artificial Drugs or Chemicals

    #1 Oral Germ Killer

    Instant Pain Relief

    CUROXEN® ORAL CARE

    A Homeopathic Medicine that provides pain relief, speeds healing, and helps prevent Infection in mouth sores

    Pain relief and treatment of:

    • Canker sores
    • Cheek bites
    • Cold sores, and abrasions from braces & dentures

    Mouth Sore Treatment

    • Pain Relief
    • Healing
    • Fights Infection

    NET WT 0.42 oz (11.9 g)

    Curoxen Oral Revised

  • INGREDIENTS AND APPEARANCE
    CUROXEN ORAL CARE 
    olive extract, calendula, clove oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOVE OIL (UNII: 578389D6D0) (CLOVE OIL - UNII:578389D6D0) CLOVE OIL1 [hp_X]  in 12 g
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J) OLEA EUROPAEA FRUIT VOLATILE OIL2 [hp_X]  in 12 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-004-121 in 1 CARTON12/20/2017
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2017
    Labeler - OrganiCare Nature's Science, LLC (044204745)
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