SPL v4
SPL
SPL Set ID 417bc541-df30-cb8a-e063-6294a90af49f
Route
TOPICAL
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (10 mg)
Inactive Ingredients
Iodopropynyl Butylcarbamate Water Fd&c Yellow No. 5 Alcohol Propylene Glycol Methylisothiazolinone Anhydrous Citric Acid Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-27

Description

Gently shake bottle. Hold upright and press pump until spray dispenses. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 5-15 minutes before intercourse or use as directed by a doctor. Wash product off after intercourse.

Purpose

Male Genital Desensitizer


Medication Information

Purpose

Male Genital Desensitizer

Description

Gently shake bottle. Hold upright and press pump until spray dispenses. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 5-15 minutes before intercourse or use as directed by a doctor. Wash product off after intercourse.

Uses

helps in temporarily slowing the onset of ejaculation

Warnings

For external use only

Do not use

■ in the eyes

■ over large areas of the body

■ if allergic to any ingredient in this product

■ more than 1 week unless directed by a doctor

Ask a doctor before use if you have

■ any concerns about using this product

When using this product

■ avoid contact with the eyes

Stop use and ask a doctor if

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

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.

Label.jpg

label.jpeg

Inactive Ingredients

alcohol, citric acid, FD&C yellow no. 5, FD&C yellow no. 6, iodopropynyl butylcarbamate, methylisothiazolinone, nonylphenol ethoxylate, propylene glycol, water

Dosage & Administration

Gently shake bottle. Hold upright and press pump until spray dispenses. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 5-15 minutes before intercourse or use as directed by a doctor. Wash product off after intercourse.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

helps in temporarily slowing the onset of ejaculation

Purpose

Male Genital Desensitizer

Warnings

For external use only

Do not use

■ in the eyes

■ over large areas of the body

■ if allergic to any ingredient in this product

■ more than 1 week unless directed by a doctor

Ask a doctor before use if you have

■ any concerns about using this product

When using this product

■ avoid contact with the eyes

Stop use and ask a doctor if

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

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.

Label.jpg (label.jpg)

label.jpeg

Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, FD&C yellow no. 5, FD&C yellow no. 6, iodopropynyl butylcarbamate, methylisothiazolinone, nonylphenol ethoxylate, propylene glycol, water

Dosage & Administration (Dosage & administration)

Gently shake bottle. Hold upright and press pump until spray dispenses. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 5-15 minutes before intercourse or use as directed by a doctor. Wash product off after intercourse.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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