KY DURATION FOR MEN- lidocaine spray, metered

KY by

Drug Labeling and Warnings

KY by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Lidocaine USP 9.6% (approximately 10mg per spray)

Purpose

Male Genital Desensitizer

Uses

• Helps in the prevention of premature ejaculation
• Helps in temporarily prolonging the time until ejaculation

Warnings

For external use only

Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.

Avoid contact with the eyes

If you or your partner develop rash or irritation, such as burning or itching discontinue use. If symptoms persist, consult a doctor.

If pregnant or breastfeeding, ask a health professional before use

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 the head and shaft of the penis before intercourse, or use as directed by a doctor
• Wash product off after intercourse
• Do not use more than 20 sprays in 24 hours

Other information

• Storage instructions: Store below 30°C (86°F).
• This product is not compatible with condoms.
• The bottle is child resistant. Instructions for opening are included in the leaflet.
• Read the instructions for use and advice inside this pack carefully to achieve best results.

Inactive ingredients

ethoxydiglycol, fragrance, isopropyl myristate, stearic acid

Questions?

1-800-756-5488

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Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in Taiwan

PRINCIPAL DISPLAY PANEL - 5.0 mL Bottle Label

K♦Y
DURATION™
SPRAY FOR MEN

Male Genital Desensitizer
Lidocaine USP 9.6% (approximately 10mg per spray)

LAST LONGER
STAY IN THE MOMENT

36 SPRAYS
0.16 fl oz (5.0 mL)

INGREDIENTS AND APPEARANCE

KY   DURATION FOR MEN
lidocaine spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	96 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Stearic Acid (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-257-01	5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2016
2	NDC: 63824-257-02	10.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	09/01/2016

Labeler - RB Health (US) LLC (081049410)