Label: EJECTDELAY GEL- benzocaine 7.5% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 6, 2013

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  • Active Ingredients

    Benzocaine 7.5%

  • Purpose

    Male genital desensitizer

  • Indications

    Helps in the prevention of premature ejaculation

  • Warnings

    For external use only

  • SPL UNCLASSIFIED SECTION

  • When using this product

    Avoid contact with eyes

  • Stop use and ask a doctor if

    • Premature ejaculation may be due to a condition requiring medical supervision
    • This product, used as directed, does not provide relief, discontinue use and consult a physician
    • You or your partner develop a rash or irritation, such as burning or itching, discontinue use
    • If symptoms persist, consult a doctor
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician.

    Wash product off after intercourse

  • Inactive Ingredients

    Glycerin Natural USP Kosher, PEG 8 Pluracol E 400 NF, PEG 3350, PEG 540 Blend USP, Carbowax 4000, Sodium Saccharin Powder USP, Sorbic Acid, Water

  • Questions or Comments

    For questions or comments please call 1-858-964-5123

  • PRINCIPAL DISPLAY PANEL

    Image of Carton and Label

  • INGREDIENTS AND APPEARANCE
    EJECTDELAY  GEL
    benzocaine 7.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-003-071 in 1 BOX
    1NDC:57483-003-0356.8 g in 1 TUBE
    2NDC:57483-003-085 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/15/2013
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Registrant - Innovus Pharmaceuticals, Inc. (962507187)
    Establishment
    NameAddressID/FEIBusiness Operations
    U.S. Pharmaceuticals, Inc.009248480manufacture(57483-003)
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