Label: 12 MALE REPRODUCTIVE- chimaphila umbellata, pituitary, sabal serrulata, uva-ursi, gelsemium sempervirens, sarsaparilla, kali phosphoricum, phosphoricum acidum, zincum metallicum 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 June 29, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Chimaphila umbellata 3X, Pituitary 3C, Sabal serrulata 6C, Uva-ursi 6C, Gelsemium sempervirens 30C, Sarsaparilla 30C, Kali phosphoricum 1M, Phosphoricum acidum 1M, Zincum metallicum 1M.

  • PURPOSE

    INDICATIONS:  For the temporary relief of emotionlessness, denial, numbness and unresponsiveness.

  • WARNINGS

    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.


  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT


    INACTIVE INGREDIENTS:  Demineralized water, 25% Alcohol


  • QUESTIONS

    MFG. FOR: 

    Theresa Dale, N.D.

    1237 S. Victoria Ave.

    Oxnard, CA 93035

    1-868-962-6484


  • PRINCIPAL DISPLAY PANEL

    Dr. Theresa Dale's

    Homeopathic

    Neuro0Emotional Remedies

    #12 MALE REPRODUCTIVE PITUITARY/TESTES/PROSTATE

    Unresponsive

    1 fl oz (30 ml)

    12 Male Reproductive

  • INGREDIENTS AND APPEARANCE
    12 MALE REPRODUCTIVE 
    chimaphila umbellata, pituitary, sabal serrulata, uva-ursi, gelsemium sempervirens, sarsaparilla, kali phosphoricum, phosphoricum acidum, zincum metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0494
    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) (POTASSIUM CATION - UNII:295O53K152) 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:57520-0494-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/18/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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