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 28, 2009

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

  • SPL UNCLASSIFIED SECTION

    Homeopathic Analgesic Medicine

  • lndications

    For temporary relief of pain of bruises, sprains, swelling of joints and muscles.

  • INGREDIENTS

    10 mL Mucor racemosus 5X in a base of purified water.

  • Tamper Evident

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

  • DOSAGE

    5–10 drops, once daily, before mealtime.

  • PURPOSE

  • WARNING

    lf symptoms persist more than a few days, contact a licensed practitioner. As with other drugs, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all other medications out of the reach of children. ln case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • SPL UNCLASSIFIED SECTION

    Made in Germany

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

    Manufactured By:
    Sanum-Kehlbeck
    GmbH & Co. KG

  • PRINCIPAL DISPLAY PANEL - 10 mL label

    Pleo™ Muc DROPS 5X

    Homeopathic Analgesic Medicine

    lndications: For temporary relief of pain of bruises,
    sprains, swelling of joints and muscles.

    0.34 fl oz (10 mL)

    DOSAGE: 5-10 drops, once daily, before mealtime. WARNING: If symptoms persist more
    than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or
    nursing a baby, seek the advice of a health care professional before using this product.
    Keep this and all medications out of the reach of children. In case of accidental
    overdose, seek professional assistance or contact a Poison Control Center immediately.
    Protect from light and heat. TAMPER EVIDENT: Do not use this product if tamper-evident
    seal on base of bottle cap is missing or broken. INGREDIENTS: 10 mL Mucor racemosus
    5X in a base of purified water.
    Rev. 06/2009

    Principal Display Panel - 10 mL label
  • PRINCIPAL DISPLAY PANEL - 10 mL carton

    Pleo™ Muc
    DROPS 5X

    Homeopathic
    Analgesic
    Medicine

    lndications:
    For temporary
    relief of pain of
    bruises, sprains,
    swelling of joints
    and muscles.

    ORIGINAL ENDERLEIN

    0.34 fl oz
    (10 mL)

    Principal Display Panel- 10 mL carton
  • INGREDIENTS AND APPEARANCE
    PLEO MUC 
    mucor racemosus solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    mucor racemosus (UNII: 17RH99LQ7G) (mucor racemosus - UNII:17RH99LQ7G) mucor racemosus5 [HP_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1801-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/09/1996
    Labeler - SANUM-KEHLBECK GMBH & CO KG (318386133)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANUM-KEHLBECK GMBH & CO KG318386133Manufacture