Label: SABAL SERRULATUM- sabal serulatum, lycopodium clavatum, pareira brava liquid

  • NDC Code(s): 60986-1009-3, 60986-1009-4
  • Packager: Marco Pharma International 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 December 9, 2021

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  • Active Ingredients

    Saw Palmetto 1xHPUS

    Club Moss 4xHPUS

    Pareira 4xHPUS

    The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

    Purpose

    For relief of difficult urination; prostate afflictions.

    Keep out of reach of children.

    Suggested use

    In acute disorders, take 10 drops in pure water every hour until improvement is felt. Then take 25 drops in pure water three times daily after or between meals.

    Warnings

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

    (Read Suggested Use Section)

    Inactive Ingredients

    Ethyl alcohol (65% by vol.) and water.

  • PRINCIPAL DISPLAY PANEL

    Sabal_N1S152_N1L152

  • INGREDIENTS AND APPEARANCE
    SABAL SERRULATUM 
    sabal serulatum, lycopodium clavatum, pareira brava liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-1009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO1 [hp_X]  in 100 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 100 mL
    CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT4 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60986-1009-350 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/28/2018
    2NDC:60986-1009-4100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/1992
    Labeler - Marco Pharma International LLC. (161994277)
    Registrant - Marco Pharma International LLC. (161994277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nestmann Pharma GmbH323426262manufacture(60986-1009)
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