FDA.reportPublic FDA data

Skyn Endurance Delay Spray For Men

Manufacturer
Sxwell USA, LLC
Effective date
2021-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:55:33

Label at a glance#

ProductSkyn Endurance Delay For Men
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

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

Dosage and administration

• Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. • Wash product off after intercourse.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine USP (12.5%) (Approximately 10 mg Per Spray)

Purpose

OTC - PURPOSE SECTION

Male Genital Desensitizer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

this product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredients. Do not use on broken or inflamed skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• This product, used as directed, does not provide relief, discontinue use and consult a doctor. Premature ejaculation may be due to a condition requiring medical supervision.
• You or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor.
• Wash product off after intercourse.

Other Information

SPL UNCLASSIFIED SECTION

• Do not use if temper evident tab is damaged.
• The package is child resistant.
• Store at room temperature (68-77F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Myristate, L-Arginine, Peppermint Oil, Phenoxyethanol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackageBoxBox

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73115-00073115-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ARGININE94ZLA3W45FIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LIDOCAINE98PI200987ACTIB

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
ec92e832-b6d1-c943-e053-2a95a90ac3134474e124-a7d7-41ce-a9ff-aac06b08f6a32022-11-03WarningsExact identifier
spl set id: 4474e124-a7d7-41ce-a9ff-aac06b08f6a3

Reported adverse events (FAERS/openFDA)#

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