SKYN ENDURANCE DELAY FOR MEN- lidocaine liquid
Sxwell USA, 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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Skyn Endurance Delay Spray For Men

Drug Facts

Active ingredients

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

Purpose

Male Genital Desensitizer

Uses

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

Warnings

For external use only

Do not use

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

avoid contact with eyes.

Stop use and ask a doctor if

• 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.

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

Directions

• 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

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

Inactive ingredients

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

Package Labeling:

Outer Package Inner Package Box

SKYN ENDURANCE DELAY FOR MEN
lidocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73115-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	125 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ARGININE (UNII: 94ZLA3W45F)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73115-000-01	1 in 1 BOX	06/01/2019	09/15/2022
1		5.1 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/01/2019	09/15/2022

Labeler - Sxwell USA, LLC (080650902)

Revised: 11/2022

Document Id: ec92e832-b6d1-c943-e053-2a95a90ac313

Set id: 4474e124-a7d7-41ce-a9ff-aac06b08f6a3

Version: 3

Effective Time: 20221103

Sxwell USA, LLC