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

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

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  • 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.

  • INDICATIONS:

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

  • 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.

  • 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.

  • 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.

  • INDICATIONS:

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

  • INACTIVE INGREDIENTS:

    Purified Water, Organic Ethanol 30%

  • QUESTIONS:

    Distributed By ProBLEN

    2850 Shoreline Trail

    Rockwall, TX 75032

    www.problen.com

  • PACKAGE LABEL DISPLAY:

    Testosterone

    HOMEOPATHIC

    ORGANOTHERAPY

    1.0 FL OZ (30 ML)

    proBLEN

    Testosterone lbl

    Testosterone ctn

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43853-0005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 1 mL
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED1 [hp_X]  in 1 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG1 [hp_X]  in 1 mL
    GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE3 [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 BARK1 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER6 [hp_X]  in 1 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG1 [hp_X]  in 1 mL
    NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT2 [hp_X]  in 1 mL
    BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H) BOS TAURUS TESTICLE6 [hp_X]  in 1 mL
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK1 [hp_X]  in 1 mL
    POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF1 [hp_X]  in 1 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE30 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43853-0005-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/16/2013
    Labeler - ProBLEN (838787161)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43853-0005) , api manufacture(43853-0005) , label(43853-0005) , pack(43853-0005)
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