Prolayed (Lidocaine) Ointment [Viaderma, Inc] -

PROLAYED (LIDOCAINE) OINTMENT [VIADERMA, INC]
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NDC	69006-010-00
Set ID	8f04d65e-f681-4e3b-9b86-622debb9cfd0
Category	HUMAN OTC DRUG LABEL
Packager	ViaDerma, Inc
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART333B

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69006-010-00	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2017

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

Labeler - ViaDerma, Inc (079387584)

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