Label: TESTOSTERONE- avena sativa, baryta carbonica, carduus mar, damiana, hamamelis virg, hepar, korean ginseng, nuphar, orchitinum, phosphoricum acidum, populus trem, sabal serulata, selenium metallicum, testosterone. 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 November 30, 2017

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

  • ACTIVE INGREDIENT

    ​Active Ingredients Equal Parts Of: Avena Sativa 1X, Baryta Carbonica 8X, Carduus Mar 1X, Damiana 1X, Hamamelis Virg 1X, Hepar 6X, Korean Ginseng 1X, Nuphar 2X, Orchitinum 6X, Phosphoricum Acidum 12X, Populus Trem 1X, Sabal Serulata 6X, Selenium Metallicum 12X, Testosterone​ ​30X.​

  • INDICATIONS & USAGE

    ​Indications: ​Temporarily supports the body to rebalancet tesosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

  • WARNINGS

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

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    ​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.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    ​Inactive Ingredients: ​Organic Alcohol 20% v/v, Purified Water​

  • QUESTIONS

    Distributed By ProBlen (888) 326-2121 www. problen.com

    3021 Ridge Rd. Rockwall, TX 75032

  • PRINCIPAL DISPLAY PANEL

    NDC: 43853-0021-1

    Testosterone

    HOMEOPATHIC ORGANOTHERAPY

    1.0 FL OZ. (30ML) 20% ALCOHOL

    ProBlen

    1oz bottle label

    Temporarily supports the body to rebalancet tesosterone output.

  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE 
    avena sativa, baryta carbonica, carduus mar, damiana, hamamelis virg, hepar, korean ginseng, nuphar, orchitinum, phosphoricum acidum, populus trem, sabal serulata, selenium metallicum, testosterone. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43853-0021
    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 30 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE8 [hp_X]  in 30 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE1 [hp_X]  in 30 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG1 [hp_X]  in 30 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 30 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER6 [hp_X]  in 30 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG1 [hp_X]  in 30 mL
    NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEA ROOT - UNII:714LIU3V6D) NUPHAR LUTEA ROOT2 [hp_X]  in 30 mL
    SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE6 [hp_X]  in 30 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 30 mL
    POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF1 [hp_X]  in 30 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO6 [hp_X]  in 30 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM12 [hp_X]  in 30 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE30 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43853-0021-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/28/2017
    Labeler - ProBlen (838787161)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(43853-0021)