Your browser does not support JavaScript! PLEASURE BALM KAMA SUTRA (BENZOCAINE) GEL [KAMA SUTRA]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

PLEASURE BALM KAMA SUTRA (benzocaine) gel
[Kama Sutra]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active Ingredients           Purpose

Benzocaine 5.0 %           Male genital desensitizer

Use

Helps in temporarily prolonging time until ejaculation

Keep out of reach of children. If swallowed, seek medical assistance or contact a Poison Control Center immediately.

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

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.

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 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)

Carton

Core packaging

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

PLEASURE BALM  KAMA SUTRA
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:75956-147
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75956-147-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/12/2013
Labeler - Kama Sutra (053877858)
Registrant - Kama Sutra (053877858)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Technologies830157012manufacture(75956-147)

Revised: 9/2013
 
Kama Sutra

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services