drug facts:

drug facts:
SPL v1
SPL
SPL Set ID c8e6a948-e863-4322-9dd5-814c8d1995eb
Route
topical
Published
Effective Date 2011-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (6.39 g)
Inactive Ingredients
water petrolatum propylene glycol cyclomethicone 5 mineral oil glyceryl monostearate polysorbate 60 glycol distearate glycerin coconut oil diazolidinyl urea methylparaben propylparaben fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2011-05-23

Purpose

Male genital desensitizer

Description

Benzocaine 7.5%


Medication Information

Warnings

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 physician
  • Avoid contact with the eyes. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use
  • If symptoms persist, consult a physician
Purpose

Male genital desensitizer

Directions

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician

  • Wash product off after intercourse.

Inactive Ingredients

Water, Petrolatum, Propylene Glycol, Cyclopentasiloxane, Mineral Oil, Glyceryl Stearate Se, Polysorbate 60, Glycol Distearate, Glycerin, Coconut Oil, Germall 11, Methylparaben, Propylparaben, Yellow 5

Description

Benzocaine 7.5%

Section 51945-4

Placeholder Text

Indications
  • Helps in the prevention of premature ejaculation
  • For temporary male genital desensitization, helping to slow the onset of ejaculation

  • Helps in temporarily slowing the onset of ejaculation
  • For reducing oversensitivity in the male in advance of intercourse



Active Ingredients

Benzocaine 7.5%

Questions Or Comments

For questions or comments please call 1-818-888-6825.

Keep Out of Reach of Children

Enter section text here


Structured Label Content

Warnings

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 physician
  • Avoid contact with the eyes. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use
  • If symptoms persist, consult a physician
Purpose

Male genital desensitizer

Directions

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician

  • Wash product off after intercourse.

Inactive Ingredients

Water, Petrolatum, Propylene Glycol, Cyclopentasiloxane, Mineral Oil, Glyceryl Stearate Se, Polysorbate 60, Glycol Distearate, Glycerin, Coconut Oil, Germall 11, Methylparaben, Propylparaben, Yellow 5

Section 51945-4 (51945-4)

Placeholder Text

Indications
  • Helps in the prevention of premature ejaculation
  • For temporary male genital desensitization, helping to slow the onset of ejaculation

  • Helps in temporarily slowing the onset of ejaculation
  • For reducing oversensitivity in the male in advance of intercourse



Active Ingredients

Benzocaine 7.5%

Questions Or Comments (Questions or Comments)

For questions or comments please call 1-818-888-6825.

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

Enter section text here


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)