FDA.reportPublic FDA data

KY ® Duration ® Gel for Men

Manufacturer
RB Health (US) LLC
Effective date
2022-01-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:12:38

Label at a glance#

ProductKY Duration for Men
Active ingredientBenzocaine
Label structure11 sections

Indications and uses

helps in the prevention of premature ejaculation helps in temporarily prolonging the time until ejaculation

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine USP 7%

Purpose

OTC - PURPOSE SECTION

Male Genital Desensitizer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - STOP USE SECTION

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.

OTC - WHEN USING SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B, polyethylene glycol

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 5 mL Can Carton Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-25963824-259-01, 63824-259-02, 63824-259-04, 63824-259-03, 63824-259-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BenzocaineU3RSY48JW5ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)K6MOM3T5YLIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00ddda6a-1923-90d4-e063-6394a90a8a46e10445c0-e8ff-47fb-ac45-992950e28ea22023-07-19WarningsExact identifier
spl set id: e10445c0-e8ff-47fb-ac45-992950e28ea2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.