EJECTDELAY CREAM- benzocaine cream 
Innovus Pharmaceuticals, Inc.

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.

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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

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

Water, Petrolatum, Propylene Glycol, Cyclopentasiloxane, Mineral Oil, Glyceryl Stearate Se, Polysorbate 60, Glycol Distearate, Glycerin, Coconut Oil,  Germall 11, Methylparaben, Propylparaben, Yellow 5 

Questions or Comments

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

Image of Carton and Label

EJECTDELAY  CREAM
benzocaine 7.5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
PROPYLENE GLYCOL 
CYCLOMETHICONE 5 
MINERAL OIL 
GLYCERYL STEARATE SE 
POLYSORBATE 60 
GLYCOL DISTEARATE 
GLYCERIN 
COCONUT OIL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:57483-002-021 in 1 BOX
1NDC:57483-002-0156.8 g in 1 TUBE
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
Creations Garden Natural Products, Inc.961956229manufacture(57483-002)

Revised: 07/2013
Document Id: 0f9b97f2-2ca6-4e47-960f-4b5e15f754fd
Set id: 61874e60-14d6-49c4-ac29-a13bc74f216c
Version: 5
Effective Time: 20130712
 
Innovus Pharmaceuticals, Inc.