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.​

    Close
  • INDICATIONS & USAGE

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

    Close
  • 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.
    Close
  • 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.

    Close
  • OTHER SAFETY INFORMATION

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

    Close
  • INACTIVE INGREDIENT

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

    Close
  • QUESTIONS

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

    3021 Ridge Rd. Rockwall, TX 75032

    Close
  • 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.

    Close
  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:43853-0021
    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 30 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 8 [hp_X]  in 30 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 1 [hp_X]  in 30 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG 1 [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 BARK 1 [hp_X]  in 30 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 6 [hp_X]  in 30 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG 1 [hp_X]  in 30 mL
    NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEA ROOT - UNII:714LIU3V6D) NUPHAR LUTEA ROOT 2 [hp_X]  in 30 mL
    SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE 6 [hp_X]  in 30 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X]  in 30 mL
    POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF 1 [hp_X]  in 30 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO 6 [hp_X]  in 30 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 12 [hp_X]  in 30 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 30 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43853-0021-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/28/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/28/2017
    Labeler - ProBlen (838787161)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    Name Address ID/FEI Business Operations
    OHM PHARMA INC. 030572478 manufacture(43853-0021)
    Close