Label: MALE TONICITY- american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm dna, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger spray

  • 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 August 8, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients: Equal volumes of each ingredient: 

    aralia quinquefolia 3X HPUS, arnica montana 3X HPUS, damiana 2X HPUS, DNA 6X HPUS, galium aparine 3X HPUS, hamamelis virginiana 3X HPUS, hepar suis 6X HPUS, oleum animale 8X HPUS, orchitinum 6X HPUS, phosphoricum acidum 200C HPUS, pituitarium posterium 8X HPUS, thuja occidentalis 3X HPUS, thyroidinum 12X HPUS, tribulus terrestris 2X HPUS, zingiber officinale 3X HPUS.

  • PURPOSE

    Male Tonicity

    Energy Medicine with DNA

    Homeopathic Fast-Acting Oral Spray

    1.0 Fl Oz (30 ml)

    Alcohol 9% v/v

    Sunway Biotech

    Scientifically Tested

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions: Adults Only: Spray twice under the tongue, three times a day. This bottle contains about a 1 month supply.

  • WARNINGS

    Warnings: Stop use and ask a doctor if symptoms persist more than 3 days, worsen, or if new symptoms occur.

    Tamper Evident Seal: Do not use if seal around neck of bottle is broken or missing. The letters HPUS indicate that ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

  • INDICATIONS & USAGE

    Indications: Temporarily relieves symptoms of low male sexual energy, including: decrease in sexual desire; feelings of fatigue; decrease in performance and enjoyment.

  • INACTIVE INGREDIENT

    Inactive Ingredients: alcohol 9% v/v, glycerin 10% v/v, purified water.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    MALE TONICITY 
    american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm dna, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55138-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG1.5 [hp_C]  in 1 mg
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1.5 [hp_C]  in 1 mg
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG1 [hp_C]  in 1 mg
    HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA3 [hp_C]  in 1 mg
    GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE1.5 [hp_C]  in 1 mg
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1.5 [hp_C]  in 1 mg
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER3 [hp_C]  in 1 mg
    CERVUS ELAPHUS HORN OIL (UNII: 7A7G0PQI12) (CERVUS ELAPHUS HORN OIL - UNII:7A7G0PQI12) CERVUS ELAPHUS HORN OIL4 [hp_C]  in 1 mg
    OVIS ARIES TESTICLE (UNII: P873TP6713) (OVIS ARIES TESTICLE - UNII:P873TP6713) OVIS ARIES TESTICLE3 [hp_C]  in 1 mg
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID200 [hp_C]  in 1 mg
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND4 [hp_C]  in 1 mg
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG1.5 [hp_C]  in 1 mg
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED6 [hp_C]  in 1 mg
    TRIBULUS TERRESTRIS (UNII: 4X4HLN92OT) (TRIBULUS TERRESTRIS - UNII:4X4HLN92OT) TRIBULUS TERRESTRIS1 [hp_C]  in 1 mg
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER1.5 [hp_C]  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55138-013-0130 mg in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/08/2014
    Labeler - Integra Health International, S.A. de C.V. (589880301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Integra Health International, S.A. de C.V.589880301manufacture(55138-013)
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