PLEASURE BALM KAMA SUTRA- benzocaine gel

Pleasure Balm by

Drug Labeling and Warnings

Pleasure Balm 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 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)

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

INGREDIENTS AND APPEARANCE

PLEASURE BALM  KAMA SUTRA
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75956-147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
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: 75956-147-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	09/12/2013

Labeler - Kama Sutra (053877858)

Registrant - Kama Sutra (053877858)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprise		017701475	manufacture(75956-147)