SPL v1
SPL
SPL Set ID 60b7577d-53a9-4f6f-e053-2991aa0a4480
Route
TOPICAL
Published
Effective Date 2017-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (4.2 g)
Inactive Ingredients
Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Propylene Glycol Trolamine Methylparaben Diazolidinyl Urea Propylparaben American Ginseng Diethylene Glycol Monoethyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-19
Description

Benzocaine - 7.5%

Medication Information

Warnings and Precautions
  • 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.
  • For external use only.
  • Avoid contact with eyes.
  • Discontinue use if you or your partner develops rash or irritation, such as burning or itching.
Indications and Usage

Helps in temporarily slowing the onset of ejaculation.

Dosage and Administration
  • Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor.
  • Rub product into the skin of the penis until it is absorbed.
  • Remove any excess to avoid any unwanted numbing before intercourse.
  • Wash product off after intercourse.
Description

Benzocaine - 7.5%

Section 50565-1
  • Keep out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
  • If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
Section 51727-6

Carbomer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Panax Ginseng Root Extract, Propylene Glycol, Propylparaben, Purified Water (Aqua), Triethanolamine.

Section 51945-4

Section 55105-1

Male Genital Desensitizer

Section 55106-9

Benzocaine - 7.5%

Section 60561-8
  • Store at room temperature 20°-25°C (68°-77°F).
  • Tamper-Evident: Do not use if seal under cap is broken or missing.

Structured Label Content

Indications and Usage (34067-9)

Helps in temporarily slowing the onset of ejaculation.

Dosage and Administration (34068-7)
  • Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor.
  • Rub product into the skin of the penis until it is absorbed.
  • Remove any excess to avoid any unwanted numbing before intercourse.
  • Wash product off after intercourse.
Warnings and Precautions (34071-1)
  • 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.
  • For external use only.
  • Avoid contact with eyes.
  • Discontinue use if you or your partner develops rash or irritation, such as burning or itching.
Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
  • If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
Section 51727-6 (51727-6)

Carbomer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Panax Ginseng Root Extract, Propylene Glycol, Propylparaben, Purified Water (Aqua), Triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Male Genital Desensitizer

Section 55106-9 (55106-9)

Benzocaine - 7.5%

Section 60561-8 (60561-8)
  • Store at room temperature 20°-25°C (68°-77°F).
  • Tamper-Evident: Do not use if seal under cap is broken or missing.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.924234 · Updated: 2026-03-14T22:54:57.020531