Pleasure Balm

Pleasure Balm
SPL v19
SPL
SPL Set ID f370e3c4-65ca-4f3c-a5aa-70e198e681a2
Route
TOPICAL
Published
Effective Date 2018-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5 g)
Inactive Ingredients
Fd&c Blue No. 1 Edetate Disodium Cetyl Hydroxyethylcellulose (350000 Mw) Mentha Piperita Polyethylene Glycol 400 Polysorbate 60 Propylene Glycol Saccharin Sodium Water Fd&c Yellow No. 5 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-12

Description

Active Ingredients           Purpose Benzocaine 5.0 %           Male genital desensitizer


Medication Information

Warnings and Precautions

Warnings

DO NOT use if allergic to Benzocaine or any other ingredient in this product

If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away.

Premature ejaculation may be due to condition requiring medical supervision

Consult a doctor prior to use if partner is pregnant

Avoid contact with eyes: if this happens, rinse thoroughly with water

Known adverse reactions   Hypersensitivity/allergy has been known to occur, in such a case, discontinue use.

Indications and Usage

Discontinue use and consult a doctor if

This product, used as directed does not provide relief

You or your partner develops a rash or irritation, such as burning or itching

Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use

Dosage and Administration

Directions for use

Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only.

Description

Active Ingredients           Purpose Benzocaine 5.0 %           Male genital desensitizer

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

Section 51945-4

Pleasure Balm

Prolonging Gel for Men

Male Genital Desensitizer

Desensibilisateur Genital Pour hommes

0.4 fl oz  12 ml

Section 55105-1

Use

Helps in temporarily prolonging time until ejaculation

Section 55106-9

Active Ingredients           Purpose

Benzocaine 5.0 %           Male genital desensitizer


Structured Label Content

Indications and Usage (34067-9)

Discontinue use and consult a doctor if

This product, used as directed does not provide relief

You or your partner develops a rash or irritation, such as burning or itching

Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use

Dosage and Administration (34068-7)

Directions for use

Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only.

Warnings and Precautions (34071-1)

Warnings

DO NOT use if allergic to Benzocaine or any other ingredient in this product

If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away.

Premature ejaculation may be due to condition requiring medical supervision

Consult a doctor prior to use if partner is pregnant

Avoid contact with eyes: if this happens, rinse thoroughly with water

Known adverse reactions   Hypersensitivity/allergy has been known to occur, in such a case, discontinue use.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

Section 51945-4 (51945-4)

Pleasure Balm

Prolonging Gel for Men

Male Genital Desensitizer

Desensibilisateur Genital Pour hommes

0.4 fl oz  12 ml

Section 55105-1 (55105-1)

Use

Helps in temporarily prolonging time until ejaculation

Section 55106-9 (55106-9)

Active Ingredients           Purpose

Benzocaine 5.0 %           Male genital desensitizer


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)