Label: MALE ENDOCRINE AXIS DROPS 5019- male endocrine axis drops 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Populus tremuloides 1X
    Sabal serrulata 1X
    Solidago virgaurea 2X
    Pygeum africanum 3X
    Sarsaparilla 3X
    Zincum metallicum 3X
    Damiana 4X
    Adrenal 6X
    Ferrum picricum 6X
    Orchic 6X
    Pituitary 6X
    Prostate 6X
    Selenium metallicum 6X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of diminished sexual desire or performance, muscle weakness or decreased strength, sleep disturbances, weight gain, frequent or difficult urination, or fatigue.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Male Endocrine Axis Drops

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    MALE ENDOCRINE AXIS DROPS  5019
    male endocrine axis drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-5019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK1 [hp_X]  in 59 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO1 [hp_X]  in 59 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP2 [hp_X]  in 59 mL
    PYGEUM (UNII: 709HYI14M4) (PYGEUM - UNII:709HYI14M4) PYGEUM3 [hp_X]  in 59 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SMILAX ORNATA ROOT - UNII:2H1576D5WG) SMILAX ORNATA ROOT3 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC3 [hp_X]  in 59 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG4 [hp_X]  in 59 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND6 [hp_X]  in 59 mL
    FERRIC CATION (UNII: 91O4LML611) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION6 [hp_X]  in 59 mL
    BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H) BOS TAURUS TESTICLE6 [hp_X]  in 59 mL
    BOS TAURUS PITUITARY GLAND, POSTERIOR (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND, POSTERIOR - UNII:7JM57I419K) BOS TAURUS PITUITARY GLAND, POSTERIOR6 [hp_X]  in 59 mL
    BOS TAURUS PROSTATE GLAND (UNII: 1P66FXU2MW) (BOS TAURUS PROSTATE GLAND - UNII:1P66FXU2MW) BOS TAURUS PROSTATE GLAND6 [hp_X]  in 59 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM6 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-5019-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-5019)
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