EJECTDELAY GEL- benzocaine gel 
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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Drug Facts

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

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

Image of Carton and Label

EJECTDELAY  GEL
benzocaine 7.5% gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57483-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 3350  
POLYETHYLENE GLYCOL 4000  
SACCHARIN SODIUM  
SORBIC ACID  
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-003-021 in 1 BOX
1NDC:57483-003-0356.8 g in 1 TUBE
2NDC:57483-003-065 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)

Revised: 11/2013
Document Id: d4d19065-51a3-4c21-a615-060a82546328
Set id: 24a9e4e5-a418-43a2-890f-7f90cd5f5b3f
Version: 9
Effective Time: 20131112
 
Innovus Pharmaceuticals, Inc.