SPL v5
SPL
SPL Set ID 95caab25-c0c8-4b46-b3ce-7a1dd02a3dd2
Route
TOPICAL
Published
Effective Date 2021-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (7 g)
Inactive Ingredients
Water Lactic Acid, Unspecified Form Phenol Phenoxyethanol Ethylhexylglycerin Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-08

Description

Benzocaine USP 7%

Purpose

Male genital desensitizer


Medication Information

Purpose

Male genital desensitizer

Description

Benzocaine USP 7%

Uses
  • Aids in the prevention of premature ejaculation
  • Aids in temporarily prolonging the time until ejaculation
Warnings

For External Use only.

Do not use onbroken or inflamed skin.

If pregnant or breastfeeding, ask a health professional before use.

When using thisproduct, avoid contact with eyes.

Stop and ask doctor if:

This product, when used as directed, does not provide relief; premature ejaculation may be due to a condition requiring medical supervision,you or your partner develop rash or irritation, such as burning or itching  symptoms persist.

Directions

Use wipe to apply a small amount of product to the head and shape of the penis before intercourse, or as directed by a doctor. Wash off after intercourse.

Allow product to dry prior to intercourse.

Not suitable for oral use.

Use as directed.

Drug Facts

Product Label

Active Ingredient

Benzocaine USP 7%

Other Information

Store between 20°-25 °C (68°-77 °F)

Inactive Ingredients

Lactic Acid, Phenol, Phenoxyethanol, ethylhexylglycerin, Polyethylene Glycol, purified water

Keep Out of Reach of Children 

In case of ingestion, seek professional assistance and contact poison control immediately.


Structured Label Content

Uses
  • Aids in the prevention of premature ejaculation
  • Aids in temporarily prolonging the time until ejaculation
Purpose

Male genital desensitizer

Warnings

For External Use only.

Do not use onbroken or inflamed skin.

If pregnant or breastfeeding, ask a health professional before use.

When using thisproduct, avoid contact with eyes.

Stop and ask doctor if:

This product, when used as directed, does not provide relief; premature ejaculation may be due to a condition requiring medical supervision,you or your partner develop rash or irritation, such as burning or itching  symptoms persist.

Directions

Use wipe to apply a small amount of product to the head and shape of the penis before intercourse, or as directed by a doctor. Wash off after intercourse.

Allow product to dry prior to intercourse.

Not suitable for oral use.

Use as directed.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Benzocaine USP 7%

Other Information (Other information)

Store between 20°-25 °C (68°-77 °F)

Inactive Ingredients (Inactive ingredients)

Lactic Acid, Phenol, Phenoxyethanol, ethylhexylglycerin, Polyethylene Glycol, purified water

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

In case of ingestion, seek professional assistance and contact poison control immediately.


Advanced Ingredient Data


Raw Label Data

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