MALE DESENSITIZER PLEASURE BALM- benzocaine gel 
Kama Sutra

Disclaimer: 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.

----------

Pleasure Balm

Active Ingredients Purpose

Benzocaine 3.0% Male genital Desensitizer

Uses: Helps in the prevention of premature ejaculation

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

Discontinue use and consult a doctor if

This product used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.

You or your partner develop a rash or irritation, such as burning or itching.

Warnings

For external use only

Avoid contact with the eyes.

DIrections

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.

Inactive ingredients:

Water (Aqua/Eau), Alcohol SD 38B, Propylene Glycol, Polysorbate 20, Carbomer, flavor (Aroma), Sodium Hydroxide, Blue 1 (CI 42090), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

image of back label

image of front label

Kama Sutra

Pleasure Balm

Male Genital Desensitizer

1.7 fl. oz. 50ml

MALE DESENSITIZER  PLEASURE BALM
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75956-145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE3.00 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75956-145-021 in 1 BOX
1NDC:75956-145-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/14/2011
Labeler - Kama Sutra (053877858)
Registrant - Kama Sutra (053877858)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprise017701475manufacture(75956-145)

Revised: 7/2014
Document Id: 5023056c-49c6-4e78-819e-1d861d8b8302
Set id: e078b85b-7d49-4d59-9aa1-23055b9b0265
Version: 10
Effective Time: 20140731
 
Kama Sutra