Label: PRORINO DELAY- menthol, eucalyptus globulus, mentha arvensis spray

  • NDC Code(s): 71326-202-11, 71326-202-51
  • Packager: HOT PRODUCTIONS AND VERTRIEBS GMBH
  • 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 October 5, 2023

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  • ACTIVE INGREDIENTS

    Menthol 0.5x HPUS

    Eucalyptus Globulus Leaf Oil 0.1x HPUS

    Mentha Arvenes Leaf Oil 0.1x HPUS

  • PURPOSE

    Topical Anesthetic

  • USE

    For temporary male genital desensitization, helping to slow the onset of ejaculation.

  • WARNINGS

    Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
    Avoid contact with the eyes or broken skin.
    If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
    Do not use during the partner’s pregnancy.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Prior to the coitus apply a thin layer of the cream onto the glans and under it (glans frenulum) and spread by massaging.
    • Approximately 5 minutes later the cream will have absorbed well and will have fully developed its effect.
    • Prior to the coitus itself, the cream must be unconditionally washed off the penis and glans.
    • The effect may be increased by repeated use of the cream shortly before the coitus.
  • OTHER INFORMATION

    • Store in a cool, dry place. Protect from sunlight.
  • INACTIVE INGREDIENTS

    Alcohol Denat., Water (Aqua), Glycerin, Laureth-9, Panthenol, Lactic Acid, Limonene, Linalool

  • PRINCIPAL DISPLAY PANEL

    LBL_Prorino Delay Spray

    Drug Facts_Prorino Delay Spray

  • INGREDIENTS AND APPEARANCE
    PRORINO DELAY 
    menthol, eucalyptus globulus, mentha arvensis spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71326-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.1 g  in 100 mL
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) (MENTHA ARVENSIS LEAF OIL - UNII:1AEY1M553N) MENTHA ARVENSIS LEAF OIL0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71326-202-511 in 1 BOX08/29/2018
    1NDC:71326-202-1115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/29/2018
    Labeler - HOT PRODUCTIONS AND VERTRIEBS GMBH (300011984)
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