Label: 12 MALE REPRODUCTIVE (chimaphila umbellata, pituitaria glandula (suis), sabal serrulata, uva-ursi, gelsemium sempervirens, sarsaparilla- smilax regelii 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 September 4, 2013

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  • ACTIVE INGREDIENTS:

    Chimaphila Umbellata 3X, Pituitaria Glandula (Suis) 3C, Sabal Serrulata 6C, Uva-Ursi 6C, Gelsemium Sempervirens 30C, Sarsaparilla (Smilax Regelii) 30C, Kali Phosphoricum 1M, Phosphoricum Acidum 1M, Zincum Metallicum 1M.

  • INDICATIONS:

    For the temporary relif of emotionlessness, denial, numbness, and unresponsiveness.

  • WARNINGS:

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

    ​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Feel the emotion fully, breathe deeply-connecting breaths. Put 5 drops under tongue to release emotion. Continue 5 drops 2x daily as needed. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For the temporary relif of emotionlessness, denial, numbness, and unresponsiveness.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    MFD FOR:

    The Wellness Center for Research and Education, Inc.

    1237 S. Victoria Ave. Suite 169

    Oxnard, CA 93035

    1-866-962-6484

  • PACKAGE DISPLAY LABEL:

    Dr. Therese Dale's

    NDC 50181-0030-1

    HOMEOPATHIC

    ​N​euro-​E​motional ​R​emedies

    #12 MALE REPRODUCTIVE

    1 fl oz (30 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    12 MALE REPRODUCTIVE 
    chimaphila umbellata, pituitaria glandula (suis), sabal serrulata, uva-ursi, gelsemium sempervirens, sarsaparilla (smilax regelii) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA3 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND3 [hp_C]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO6 [hp_C]  in 1 mL
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF6 [hp_C]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]  in 1 mL
    SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA30 [hp_C]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC1 [hp_M]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID1 [hp_M]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC1 [hp_M]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0030-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/04/2013
    Labeler - The Wellness Center (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0030) , api manufacture(50181-0030) , label(50181-0030) , pack(50181-0030)
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