Label: EJECTDELAY GEL- benzocaine gel 

  • NDC Code(s): 57483-003-03, 57483-003-07, 57483-003-08
  • Packager: Innovus Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Benzocaine 7.5%

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  • Purpose

    Male genital desensitizer

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  • Indications

    Helps in the prevention of premature ejaculation

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  • Warnings

    For external use only

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  • When using this product

    Avoid contact with eyes

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  • 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
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  • Keep out of reach of children

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

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  • 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

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  • 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

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  • Questions or Comments

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

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  • INGREDIENTS AND APPEARANCE
    EJECTDELAY  GEL
    benzocaine 7.5% gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57483-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (Benzocaine) Benzocaine 7.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin  
    POLYETHYLENE GLYCOL 400  
    POLYETHYLENE GLYCOL 3350  
    POLYETHYLENE GLYCOL 4000  
    SACCHARIN SODIUM  
    SORBIC ACID  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57483-003-07 1 in 1 BOX
    1 NDC:57483-003-03 56.8 g in 1 TUBE
    2 NDC:57483-003-08 5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 07/15/2013
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Registrant - Innovus Pharmaceuticals, Inc. (962507187)
    Establishment
    Name Address ID/FEI Business Operations
    U.S. Pharmaceuticals, Inc. 009248480 manufacture(57483-003)
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