Label: PLEO MUC- mucor racemosus solution/ drops

  • 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 August 20, 2013

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  • PURPOSE

    Homeopathic Ophthalmic Demulcent Medicine

  • Indications

    For temporary relief of irritated and dry eyes.

  • Active Ingredient per 0.17 fl oz/5 mL

    5 g Mucor racemosus 5X.

  • Inactive Ingredients

    Isotonic sodium chloride solution, chlorhexidine diacetate.

  • Tamper Evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

  • DOSAGE

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

  • WARNINGS

    To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Discard 30 days after opening.

    Do not use if liquid changes color or becomes cloudy.

    Stop use and ask a doctor if you feel eye pain, vision changes, continued redness or irritation of the eye, or if condition worsens or lasts for more than 72 hours.

    Keep out of children's reach. In case of ingestion, seek professional help directly or contact a Poison Control Center.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    SANUM-Kehlbeck
    GmbH & Co. KG,
    Hoya, Germany

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

  • PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

    Pleo® Muc
    EYE DROPS
    5X

    Homeopathic
    Ophthalmic
    Demulcent
    Medicine

    The original
    SANUM®
    brand remedies

    Indications: For
    temporary relief
    of irritated
    and dry eyes.

    ORIGINAL ENDERLEIN

    0.17 fl oz
    (5 mL)

    PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO MUC 
    mucor racemosus solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1802
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    mucor racemosus (UNII: 17RH99LQ7G) (mucor racemosus - UNII:17RH99LQ7G) mucor racemosus5 [hp_X]  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1802-21 in 1 CARTON
    15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/09/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)