Label: TESTOSTERONE- avena sativa, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar bovine, korean ginseng, nuphar luteum, orchitinum (bovine), populus tremuloides, testosterone, thuja occidentalis 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 April 7, 2017

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

  • ACTIVE INGREDIENTS:

    Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.

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  • INDICATIONS:

    Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

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  • WARNINGS:

    Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness. As with all medicines, ​if you are pregnant or breast feeding,​ consult a health professional before using this product. ​Keep out of the reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

    Tamper Evident: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.

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  • KEEP OUT OF REACH OF CHILDREN:

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

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  • DIRECTIONS:

    Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

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  • INDICATIONS:

    Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

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  • INACTIVE INGREDIENTS:

    Purified Water, Organic Ethanol 30%

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  • QUESTIONS:

    Distributed By ProBLEN

    2850 Shoreline Trail

    Rockwall, TX 75032

    www.problen.com

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  • PACKAGE LABEL DISPLAY:

    Testosterone

    HOMEOPATHIC

    ORGANOTHERAPY

    1.0 FL OZ (30 ML)

    proBLEN

    Testosterone lbl

    Testosterone ctn

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  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE 
    avena sativa, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar bovine, korean ginseng, nuphar luteum, orchitinum (bovine), populus tremuloides, testosterone, thuja occidentalis liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43853-0005
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 1 [hp_X]  in 1 mL
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED 1 [hp_X]  in 1 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG 1 [hp_X]  in 1 mL
    GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE 3 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 6 [hp_X]  in 1 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG 1 [hp_X]  in 1 mL
    NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT 2 [hp_X]  in 1 mL
    BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H) BOS TAURUS TESTICLE 6 [hp_X]  in 1 mL
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK 1 [hp_X]  in 1 mL
    POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF 1 [hp_X]  in 1 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 30 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF 200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43853-0005-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/07/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/16/2013
    Labeler - ProBLEN (838787161)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43853-0005) , api manufacture(43853-0005) , label(43853-0005) , pack(43853-0005)
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