Otc - Active Ingredient
Active Ingredients Purpose
Benzocaine 5.0 % Male genital desensitizer
Pleasure Balm
FDA Label NDC 75956-147
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kama Sutra for the product Pleasure Balm (NDC 75956-147). 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. If swallowed, seek medical assistance or contact a Poison Control Center immediately.
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
Warnings
Warnings
For external use only
Do not useif allergic to Benzocaine or any other ingredient in this product
Safe to use only with latex condoms only
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
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.
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
Kama Sutra
Pleasure Balm
Prolonging Gel for Men
Male Genital Desensitizer
Gel pour Prolonger pour hommes
Genitaux Masculin Desensibilisateur
1.7 fl oz 50 ml
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