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 Kama Sutra. 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. 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


* Please review the disclaimer below.