Label: OCUMEND- arnica montana, ledum palustre kit

  • 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 March 8, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredients for Vial:

    Arnica Montana 52M 50% HPUS

    Ledum Palustre 52M 50% HPUS


    Active Ingredients for Healing Gels:

    Arnica Montana 52M 50% HPUS

    Ledum Palustre 52M 50% HPUS


  • PURPOSE

    Purpose for Vial:

    Arnica Montana 52M 50% HPUS .................................... Bruising

    Ledum Palustre 52M 50% HPUS ..................................Black Eye

    Purpose for Healing Gels:

    Arnica Montana 52M 50% HPUS .................................... Bruising

    Ledum Palustre 52M 50% HPUS ..................................Black Eye

  • INDICATIONS & USAGE

    Uses for Vial:

    For the reduction of bruising, swelling and pain.

    Uses for Healing Gels:

    For the reduction of bruising, swelling and pain.

  • WARNINGS

    Warnings for Vial:

    For external use only

    Warnings for Healing Gels:

    For external use only


  • DO NOT USE

    Do not use for Vial:

    Do not use

    • in the eyes
    • if solution becomes cloudy
    • if tamper seal is broken
    Do not use for Healing Gels:

    Do not use

    • in the eyes
    • over open wounds
    • if you have unexpected bleeding
  • STOP USE

    Stop use for Vial:

    Stop use and ask a doctor if condition worsens.

    Stop use for Healing Gels:

    Stop use and ask a doctor if condition worsens.

  • PREGNANCY OR BREAST FEEDING

    Pregnancy Warning for Vial:

    If pregnant or breast-feeding ask a health professional before use.

    Pregnancy Warning for Healing Gels:

    If pregnant or breast-feeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Children Section for Vial:

    Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Children Section for Healing Gels:

    Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions for Vial:

    Use as directed by a physician.  Pour contents of vial into sterile water.  Soak sterile gauze in water mixture and apply to affected site.

    Directions for Healing Gels:

    Use as directed by a physician.  Place healing gels on intact skin and replace as needed.

  • STORAGE AND HANDLING

    Other information for Vial:

    Store at room temperature.  Discard 30 days after opening.

    Other information for Healing Gels:

    Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive Ingredients (non-preserved) for Vial:

    Citrates, Polysorbate 80, Sodium Chloride, Sterile Water

    Inactive Ingredients for Healing Gels:

    Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

  • QUESTIONS

    Questions for Vial:

    Call 1-855-223-2762 or Email info@cearna.com

    Questions for Healing Gels:

    Call 1-855-223-2762 or Email info@cearna.com



  • DESCRIPTION

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

    Do not use if box seal is broken or missing, if peel pouches are open or if band on vial is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    OcuMend Principal Display Panel

    OcuMend Drug Facts


  • INGREDIENTS AND APPEARANCE
    OCUMEND 
    arnica montana, ledum palustre kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76277-211
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76277-211-611 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE 17 
    Part 21 VIAL 15 mL
    Part 1 of 2
    OCUMEND  HEALING TWO PACKS
    arnica montana, ledum palustre gel
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA52 [hp_M]
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG52 [hp_M]
    Inactive Ingredients
    Ingredient NameStrength
    METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    117 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/17/2012
    Part 2 of 2
    OCUMEND  STERILE VIAL
    arnica montana, ledum palustre liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA52 [hp_M]  in 15 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG52 [hp_M]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/17/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/17/2012
    Labeler - Cearna, Inc. (968104609)
    Registrant - Cearna, Inc. (968104609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Katecho, Inc.139791743manufacture