5e33cfd3-5c99-1a87-e053-2a91aa0ad7a3

SPL v1
SPL
SPL Set ID 5e33cfd3-5c99-1a87-e053-2a91aa0ad7a3
Route
topical
Published
Effective Date 2017-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (10 mg)
Inactive Ingredients
isopropyl palmitate alcohol dimethicone

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-11-17
Description

Active Ingredient Lidocaine 10mg

Medication Information

Warnings and Precautions
  • For external use only
  • Do not use if you or your partner are allergic to Lidocaine or other topical anesthetics.
  • 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 eyes.
  • Stop use and ask a doctor if you or your partner develops a rash or irritation, such as burning, or itching. If symptoms persist, consult a doctor.
  • Do not spray on broken or irritated skin.
Active Ingredient

Active Ingredient

Lidocaine 10mg

Indications and Usage

Helps in temporarily slowing the onset of ejaculation.

Dosage and Administration
  • Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a doctor.
  • Rub product onto penis until completely absorbed to prevent any unwanted numbing.
  • Wash product off after intercourse.
Description

Active Ingredient Lidocaine 10mg

Section 50565-1
  • Keep out of reach of children. If swallowed, seek medical help or contact a Posion Control Center right away.
Section 51727-6

Alcohol Denat., Isopropyl Palmitate, Dimethicone.

Section 51945-4

Section 55105-1

Male Genital Desensitizer

Section 60561-8
  • Store at 20º - 25ºC (68º-77ºF). Keep away from direct sunlight.
  • Tamper-Evident: Do not use if tamper-evident seal is broken or missing.

Structured Label Content

Warnings and Precautions (34071-1)
  • For external use only
  • Do not use if you or your partner are allergic to Lidocaine or other topical anesthetics.
  • 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 eyes.
  • Stop use and ask a doctor if you or your partner develops a rash or irritation, such as burning, or itching. If symptoms persist, consult a doctor.
  • Do not spray on broken or irritated skin.
Active Ingredient (55106-9)

Active Ingredient

Lidocaine 10mg

Indications and Usage (34067-9)

Helps in temporarily slowing the onset of ejaculation.

Dosage and Administration (34068-7)
  • Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a doctor.
  • Rub product onto penis until completely absorbed to prevent any unwanted numbing.
  • Wash product off after intercourse.
Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, seek medical help or contact a Posion Control Center right away.
Section 51727-6 (51727-6)

Alcohol Denat., Isopropyl Palmitate, Dimethicone.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Male Genital Desensitizer

Section 60561-8 (60561-8)
  • Store at 20º - 25ºC (68º-77ºF). Keep away from direct sunlight.
  • Tamper-Evident: Do not use if tamper-evident seal is broken or missing.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.863027 · Updated: 2026-03-14T22:54:56.160161