Label: PLEO MUC- mucor racemosus liquid

  • 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 February 8, 2012

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  • PURPOSE

    Homeopathic Ophthalmic Demulcent Medicine without preservatives

  • Indications

    For temporary relief of irritated and dry eyes

  • Active Ingredient per 0.017 fl oz / 0.5 ml vial

    0.05 mg Mucor racemosus

  • Inactive ingredient

    water, salt

  • Tamper Evident

    Do not use this product if tamper-evident aluminum foil is missing or broken.

  • DOSAGE

    1 drop, twice daily, into affected eye(s).

  • WARNING

    If symptoms persist, contact a licensed practitioner.

    Do not touch tip of container to any surface.

    Keep this and all other medications out of the reach of children. In case of ingestion, get professional help or contact a Poison Control Center.

    If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

    Do not use if solution changes color or becomes cloudy. The vials are for single use only and should be discarded after that use.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    SANUM USA Corp.
    1465 Slater Road
    Ferndale, WA 98248

    Manufactured by:
    Sanum-Kehlbeck
    GmbH & Co. KG

  • PRINCIPAL DISPLAY PANEL - 5 ml Carton

    Pleo® Muc EYE DROPS 5X

    10 Single use vials

    Homeopathic Ophthalmic Demulcent Medicine
    without preservatives

    Indications: For temporary relief of
    irritated and dry eyes

    The original
    SANUM®
    brand remedies

    0.17 fl oz / 5 ml (10 x 0.017 fl oz / 0.5 ml vials)

    Principal Display Panel - 5 ml Carton
  • INGREDIENTS AND APPEARANCE
    PLEO MUC 
    mucor racemosus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1822
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    mucor racemosus (UNII: 17RH99LQ7G) (mucor racemosus - UNII:17RH99LQ7G) mucor racemosus5 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1822-12 in 1 CARTON
    15 in 1 POUCH
    10.5 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/15/2011
    Labeler - Sanum Kehlbeck GmbH & Co KG (318386133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanum Kehlbeck GmbH & Co KG318386133MANUFACTURE
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