PROLAYED LIDOCAINE MALE GENITAL DESENSITIZER- lidocaine ointment

Prolayed Lidocaine Male Genital Desensitizer by

Drug Labeling and Warnings

Prolayed Lidocaine Male Genital Desensitizer by is a Otc medication manufactured, distributed, or labeled by ViaDerma Distribution, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Lidocaine 10 mg

Purpose

Male genital desenitizer

Use

Helps in temporarily slowing the onset of ejaculation.

Warnings

For external use only

When using this product

• avoid contact with the eyes.

Stop use and ask a doctor if

• this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision
• you or your partner develop a rash or irritation, such as burning or itching.

Keep out of reach of children.

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

Directions

• Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor.
• Wash product off after intercourse.

Inactive Ingredients

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling:

INGREDIENTS AND APPEARANCE

PROLAYED LIDOCAINE MALE GENITAL DESENSITIZER 
lidocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71262-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HISTIDINE (UNII: 4QD397987E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71262-006-15	1 in 1 BOX	06/23/2017
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	06/23/2017

Labeler - ViaDerma Distribution, Inc. (081113521)