PROLAYED- lidocaine ointment

Prolayed by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each spray)

Lidocaine 10 mg

Purpose

Male genital desensitizer

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, hydroxyethylcellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling:

INGREDIENTS AND APPEARANCE

PROLAYED 
lidocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69006-010
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: 69006-010-00	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/23/2017

Labeler - ViaDerma, Inc (079387584)