KY DURATION FOR MEN- benzocaine gel
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KY ®Duration ®Gel for Men

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

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)

Principal Display Panel - 5 mL Can Carton Label

KY DURATION FOR MEN
benzocaine gel

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-259-01	1 in 1 CARTON	03/19/2018	09/01/2021
1		5 mL in 1 CAN; Type 0: Not a Combination Product
2	NDC:63824-259-04	2 in 1 CARTON	04/16/2018	09/01/2021
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	09/01/2021
3	NDC:63824-259-03	0.5 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part348	03/19/2018	09/01/2021

Labeler - RB Health (US) LLC (081049410)

Revised: 7/2023

Document Id: 00ddda6a-1923-90d4-e063-6394a90a8a46

Set id: e10445c0-e8ff-47fb-ac45-992950e28ea2

Version: 5

Effective Time: 20230719

RB Health (US) LLC