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NDC 63824-0259-05 KY Duration for Men 7 g/100mL Details

KY Duration for Men 7 g/100mL

KY Duration for Men is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is BENZOCAINE.

Product Information

NDC	63824-0259
Product ID	63824-259_e14436d8-2ae3-4cfd-a4fd-191ae6212e62
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	KY Duration for Men
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	7
Active Ingredient Units	g/100mL
Substance Name	BENZOCAINE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63824-0259-05 (63824025905)

Pricing Information	N/A
NDC Package Code	63824-259-05
Billing NDC	63824025905
Package	1 POUCH in 1 PACKET (63824-259-05) / .5 mL in 1 POUCH (63824-259-03)
Marketing Start Date	2018-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e10445c0-e8ff-47fb-ac45-992950e28ea2 Details

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)

Principal Display Panel - 5 mL Can Carton Label

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

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
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part348	03/19/2018

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: e14436d8-2ae3-4cfd-a4fd-191ae6212e62

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

Version: 4

Effective Time: 20220124

Search by Drug Name or NDC

NDC 63824-0259-05 KY Duration for Men 7 g/100mL Details

KY Duration for Men 7 g/100mL

Product Information

Package

Package Images

NDC 63824-0259-05 (63824025905)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e10445c0-e8ff-47fb-ac45-992950e28ea2 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

Inactive Ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 5 mL Can Carton Label

INGREDIENTS AND APPEARANCE

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