Ejectdelay Gel (Benzocaine 7.5%) Gel [Innovus Pharmaceuticals, Inc.] -

EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]
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NDC	57483-003-03, 57483-003-07, 57483-003-08
Set ID	61874e60-14d6-49c4-ac29-a13bc74f216c
Category	HUMAN OTC DRUG LABEL
Packager	Innovus Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333B

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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

INGREDIENTS AND APPEARANCE

EJECTDELAY GEL
benzocaine 7.5% gel

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	07/15/2013

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Registrant - Innovus Pharmaceuticals, Inc. (962507187)

Name	Address	ID/FEI	Business Operations
Establishment
U.S. Pharmaceuticals, Inc.		009248480	manufacture(57483-003)

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