SPL v3
SPL
SPL Set ID d955f612-1267-f1be-e053-2995a90a5345
Route
TOPICAL
Published
Effective Date 2015-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (7.5 g)
Inactive Ingredients
Water Propylene Glycol Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-09-03

Description

Benzocaine 7.5%


Medication Information

Indications and Usage

For temporary male genital desensitization

Helps to slow the onset of ejaculation

Compatible with natural rubber latex and polyisoprene condoms

Description

Benzocaine 7.5%

Section 51945-4

Section 55105-1

Male Genital Desensitizer

Section 55106-9

Benzocaine 7.5%

Directions:

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

Wash product off after intercourse.

Other Information:

Do not expose to heat or flame.

Store at 20-30°C (68-77°F)

For External Use Only

Inactive Ingredients:

PEG-8, Propylene Glycol, Water (Aqua)

Ask A Doctor Before Use

If your partner is pregnant

If you have or have had liver or kidney problems

When Using This Product
  • Do not get into eyes or nostrils
  • Do not inhale
  • Do not exceed a maximum of 20 sprays in 24 hours
  • Always use the minimum amount effective for you
  • Allow 5-15 minutes to dry prior to intercourse

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. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

Can be used for sexcual intercourse and sex play when applied in accordance with usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.


Structured Label Content

Indications and Usage (34067-9)

For temporary male genital desensitization

Helps to slow the onset of ejaculation

Compatible with natural rubber latex and polyisoprene condoms

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Male Genital Desensitizer

Section 55106-9 (55106-9)

Benzocaine 7.5%

Directions:

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

Wash product off after intercourse.

Other Information: (Other information:)

Do not expose to heat or flame.

Store at 20-30°C (68-77°F)

For External Use Only (For external use only)

Inactive Ingredients: (Inactive ingredients:)

PEG-8, Propylene Glycol, Water (Aqua)

Ask A Doctor Before Use (Ask a doctor before use)

If your partner is pregnant

If you have or have had liver or kidney problems

When Using This Product (When using this product)
  • Do not get into eyes or nostrils
  • Do not inhale
  • Do not exceed a maximum of 20 sprays in 24 hours
  • Always use the minimum amount effective for you
  • Allow 5-15 minutes to dry prior to intercourse

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. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

Can be used for sexcual intercourse and sex play when applied in accordance with usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.


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