KY DURATION FOR MEN- benzocaine gel

KY Duration for Men by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzocaine USP 7%

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 a 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 a small amount to the head and shaft of the penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.
• use only on intact, non-inflamed skin
• allow gel to dry prior to intercourse
• not suitable for oral use
• use as directed, not more than four times per day

Other information

• store between 20-25°C (68-77°F)
• compatible with latex condoms
• child resistent closure. Instructions for opening are included in the leaflet.
• read the enclosed leaflet to achieve best results

Inactive Ingredients

carbomer homopolymer type B, polyethylene glycol

Questions?

1-800-756-5488

SPL UNCLASSIFIED SECTION

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

Made in China

PRINCIPAL DISPLAY PANEL - 5 mL Can Carton Label

NEW SMOOTH GEL

KY®
DURATION®
GEL FOR MEN

Male Genital Desensitizer
Benzocaine USP 7%

LAST LONGER
ENJOY THE MOMENT

COMPATIBLE WITH
LATEX CONDOMS

36 PUMPS
0.16 FL. OZ. (5.0 mL)

INGREDIENTS AND APPEARANCE

KY DURATION FOR MEN 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-259-01	1 in 1 CARTON	03/19/2018
1		5 mL in 1 CAN; Type 0: Not a Combination Product
2	NDC: 63824-259-04	2 in 1 CARTON	04/16/2018
2	NDC: 63824-259-02	0.5 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 63824-259-05	1 in 1 PACKET	09/01/2018
3	NDC: 63824-259-03	0.5 mL in 1 POUCH; 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	03/19/2018

Labeler - RB Health (US) LLC (081049410)