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SPL v1
SPL
SPL Set ID c6174378-6bb5-5712-e053-2995a90a1c75
Route
topical
Published
Effective Date 2021-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (7 g)
Inactive Ingredients
water edetate disodium caffeine alcohol carbomer 940 sodium hydroxide propanediol

Identifiers & Packaging

Pill Appearance
Shape: round
Marketing Status
otc monograph final active Since 2021-07-01

Purpose

Male Genital Desensitizer

Description

Benzocaine 7%


Medication Information

Warnings

For external use only.

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

Male Genital Desensitizer

Directions
  • apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse.
  • use only on intact, non-inflamed skin
  • allow gel to dry prior to intercourse
  • not suitable for oral use
  • use as directed, not more than four times per day
Other Information
  • Store between 20-25°C (68-77°F)
  • Compatible with latex condoms
  • Children resistant closure. Instructions for opening are included in the leaflet
  • Read the enclosed leaflet to achieve best results
Inactive Ingredients

Water (aqua), alcohol denatured, propylene glycol, disodium EDTA, carbomer, caffeine, sodium hydroxide

Description

Benzocaine 7%

Package Label

Active Ingredient

Benzocaine 7%

Stop Use and Ask Doctor
  • Premature ejacualtion 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 rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
When Using This Product

Avoid contact with the eyes.

If Pregnant Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Warnings

For external use only.

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

Male Genital Desensitizer

Directions
  • apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse.
  • use only on intact, non-inflamed skin
  • allow gel to dry prior to intercourse
  • not suitable for oral use
  • use as directed, not more than four times per day
Other Information (Other information)
  • Store between 20-25°C (68-77°F)
  • Compatible with latex condoms
  • Children resistant closure. Instructions for opening are included in the leaflet
  • Read the enclosed leaflet to achieve best results
Inactive Ingredients

Water (aqua), alcohol denatured, propylene glycol, disodium EDTA, carbomer, caffeine, sodium hydroxide

Package Label

Active Ingredient

Benzocaine 7%

Stop Use and Ask Doctor (Stop use and ask doctor)
  • Premature ejacualtion 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 rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
When Using This Product (When using this product)

Avoid contact with the eyes.

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

If pregnant or breast feeding, ask a health professional before use.

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

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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