PLEASURE BALM KAMA SUTRA- 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.

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Pleasure Balm

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

Revised: 1/2015
Document Id: a06013fd-3e81-4672-b660-34c16255ca07
Set id: 20ec6319-8380-4729-8f0d-0a6eb153b629
Version: 9
Effective Time: 20150115
 
Kama Sutra