Label: PROLONGZ- damiana, ginseng strip

  • 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 January 14, 2018

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  • ACTIVE INGREDIENT

    ActiveIngredients (in each strip)              Purpose

    Damiana Extract 1X (10 mg) .................... Stimulant

    Ginseng Extract 1X (10 mg) ..................... Stimulant

  • PURPOSE

    Use

    Helps in the prevention of premature ejaculation

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    PROLONGZ™

    Advanced Men's Institute

    • Power your sex drive
    • Increase Sexual performance
    • Longer lasting sex

    All Natural - Active Ingredients

    Homeopathic Sexual Enhancement Strip

    Strip Delivery technology

    60 Strips

    Strip Delivery Technology

    The ingredients in Prolongz™ by Advanced Men's Institute (AMI), have been shown to increase ejaculatory control levels of over 90% in Men. Prolongz™ is a natural supplement created for Men who want to perform at their highest level. Developed with intensive research, Prolongz™ uses the most effective natural ingredients.

    " Be the Dragon"

  • WARNINGS

    Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

    Stop use and ask a doctor if an allergic reaction to this product occurs.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults 18 years or older
    • Take 2 strips once a day. Plus 1 strip 30 minutes prior to intercourse
  • INACTIVE INGREDIENT

    Inactive Ingredients

    aspartyl-phenylpropyl methyl ester, cellulose, glycerol, pullulan, natural mint extract, stevia, water, xylitol

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PROLONGZ 
    damiana, ginseng strip
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69305-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TURNERA DIFFUSA LEAF (UNII: 812R0W1I3K) (TURNERA DIFFUSA LEAF - UNII:812R0W1I3K) TURNERA DIFFUSA LEAF1 [hp_X]  in 100 
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG1 [hp_X]  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    ADVANTAME (UNII: 3ZA6810AWX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    MINT (UNII: FV98Z8GITP)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69305-000-0160 in 1 BOX; Type 0: Not a Combination Product10/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/24/2014
    Labeler - Advanced Men's Institute LLC (079526408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Holyone Bio-Technologyco Ltd560981814manufacture(69305-000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aavishkar Oral Strips Pvt. Ltd.872196103manufacture(69305-000)
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