EJECTDELAY GEL- benzocaine 7.5% gel

EJECTDELAY by

Drug Labeling and Warnings

EJECTDELAY by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc., U.S. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EJECTDELAY  GEL
benzocaine 7.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-003-02	1 in 1 BOX
1	NDC: 57483-003-03	56.8 g in 1 TUBE
2	NDC: 57483-003-06	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)