Otc - Active Ingredient
Active Ingredients Purpose
Benzocaine 5.0 % Male genital desensitizer
Pleasure Balm Gel
FDA Label NDC 56152-1470
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprises Ltd for the product Pleasure Balm (NDC 56152-1470). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
Helps in temporarily prolonging time until ejaculation
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & 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
Warnings
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.
Dosage & 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.
Inactive Ingredient
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)
Package Label.Principal Display Panel
Pleasure Balm
Prolonging Gel for Men
Male Genital Desensitizer
Desensibilisateur Genital Pour hommes
0.4 fl oz 12 ml
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