Label: MALE POWERHOUSE- damiana, dioscorea villosa, ginkgo biloba, sabal serrulata, testosterone, withania somnifera 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 August 12, 2013

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  • ACTIVE INGREDIENTS:

  • INDICATIONS:

    Support of sex drive, libido, and male performance.

  • WARNINGS:

    ​If pregnant or breast-feeding,​ ask a health professional before use.

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

    Do not use if tamper evident seal is broken or missing.

  • STORAGE:

    Store in a cool, dry place.

  • DIRECTIONS:

    5 to 10 drops orally up to 3 times daily as directed by your health care professional. Consult a physician for use in children under 18 years of age.

  • INACTIVE INGREDIENTS:

    Demineralized Water, Ethanol 20%

  • KEEP OUT OF REACH OF CHILDREN.

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

  • INDICATIONS:

    Support of sex drive, libido, and male performance.

  • QUESTIONS:

    MFD For: Infinite Therapies of Sarasota, Inc.

    1188 N. Tamiami Trail, #205F

    Sarasota, FL 34236

  • PACKAGE DISPLAY LABEL:

    Infinite Therapies of Sarasota, Inc.

    ​Male PowerHouse

    HOMEOPATHIC

    1 fl. oz. (30 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    MALE POWERHOUSE 
    damiana, dioscorea villosa, ginkgo biloba, sabal serrulata, testosterone, withania somnifera liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54005-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG3 [hp_X]  in 1 mL
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER3 [hp_X]  in 1 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO3 [hp_X]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO3 [hp_X]  in 1 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE3 [hp_X]  in 1 mL
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) (WITHANIA SOMNIFERA ROOT - UNII:V038D626IF) WITHANIA SOMNIFERA ROOT3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54005-0002-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/12/2013
    Labeler - Infinite Therapies of Sarasota, Inc. (062334710)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(54005-0002) , api manufacture(54005-0002) , label(54005-0002) , pack(54005-0002)
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