MALE DESENSITIZER PLEASURE BALM- benzocaine gel

Male Desensitizer by

Drug Labeling and Warnings

Male Desensitizer by is a Otc medication manufactured, distributed, or labeled by Kama Sutra, Cosmetic Enterprise. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

Kama Sutra

Pleasure Balm

Male Genital Desensitizer

1.7 fl. oz. 50ml

INGREDIENTS AND APPEARANCE

MALE DESENSITIZER  PLEASURE BALM
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75956-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	3.00 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75956-145-02	1 in 1 BOX
1	NDC: 75956-145-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	02/14/2011

Labeler - Kama Sutra (053877858)

Registrant - Kama Sutra (053877858)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprise		017701475	manufacture(75956-145)