FDA Label for Pleasure Balm Kama Sutra

View Indications, Usage & Precautions

Pleasure Balm Kama Sutra Product Label

The following document was submitted to the FDA by the labeler of this product Cosmetic Enterprises Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients           Purpose

Benzocaine 5.0 %           Male genital desensitizer


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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