SHUNGA SENSATION BALM- benzocaine gel 
Eau Zone Oils and Fragrances LTD

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.

----------

Drug Facts

Active ingredient

Male Desensitizing Gel

Gel désensibilisant mâle

Active Ingredient
Benzocaine 7.5 pourcentage

Genital Desensitizer
Désensibilisant Genital


Benzocaine USP 7.5 pourcent

60ml

Warnings

■ For external use only. Keep out of reach of children ■ When using this product
avoid contact with eyes; in case of contact with eyes flush with water. ■ Do not use in large
quantities or on large body surface. ■ Do not use in case of allergy to benzocaine or to any
ingredient contained in this product.

Directions

Directions ■ Apply a small amount ( 1 to 3 cc ) to head and shaft of penis before
intercourse, or as directed by a doctor. ■ Wipe off excedent before relation.

Stop use and ask doctor if

Stop use and ask doctor if ■ This product used as directed does not provide relief.
Premature ejaculation may required medical supervision. ■ You or your partner develop a
rash or irritation, such as burning or itching. ■ Symptoms persist. ■ You experience up to
2 hours after use weakness; confusion; headache; breathing difficulty; and/or pale-, gray- or
blue-colored skin, symptoms associated with methemoglobinemia blood disorder.

Warning

Warnings

For external use only. Keep out of reach of children

When using this product avoid contact with eyes; in case of contact with eyes flush with water.

Do not use in large quantities or on large body surface.

Do not use in case of allergy to benzocaine or to any ingredient contained in this product.

Purpose

Name: SHUNGA Sensation Balm

SHUNGA Male Genital Desensitizer helps in temporarily prolonging the time until ejaculation by diminishing tactile sensations to the penis.

Purpose
Male genital desensitizer

Uses
Helps in temporarily prolonging the time of ejaculation ■ For reducing oversensitivity in the male in advance of intercourse

Directions ■ Apply a small amount ( 1 to 3 cc ) to head and shaft of penis before
intercourse, or as directed by a doctor. ■ Wipe off excedent before relation.

Non-medicinal / Inactive ingredients (I.N.C.I.)

Non-medicinal / Inactive ingredients (I.N.C.I.)
Water (aqua), peg 8, glycerin, propylene glycol, triethanolamine, carbomer, flavor (aroma),
sucralose. Colors for (I.N.C.I.): Mint : D&C Red #33 (CI17200). Vanilla: FD&C Yellow #5
(Tartrazine) (CI 19140), FD&C Red #40 (CI 16035), FD&C Blue #1 (CI 42090). Cherry and
Strawberries: FD&C Red #40 (CI 16035), D&C Red #33 (CI 17200).

Eau Zone Huiles & Fragrances Ltée, Montréal H4N 2S7
Made in/Fait au Canada ©2000 SHUNGA™ is a registered trademark. All rights reserved.

Outside box

Cherry Label

Mint Label

Vanilla Label

Strawberry Label

Directions

■ Apply a small amount ( 1 to 3 cc ) to head and shaft of penis before
intercourse, or as directed by a doctor. ■ Wipe off excedent before relation.

SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63240-5000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5.07 g  in 67.50 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 40018 g  in 67.50 g
GLYCERIN20.86 g  in 67.50 g
PROPYLENE GLYCOL15 g  in 67.50 g
WATER5.4 g  in 67.50 g
POLYSORBATE 200.66 g  in 67.50 g
CARBOMER 9400.357 g  in 67.50 g
TROLAMINE0.287 g  in 67.50 g
SUCRALOSE0.006 g  in 67.50 g
D&C RED NO. 330.0027 g  in 67.50 g
FD&C RED NO. 400.0003 g  in 67.50 g
FD&C BLUE NO. 10.0001 g  in 67.50 g
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63240-5000-21 in 1 BOX
1NDC:63240-5000-167.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/2000
SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63240-5001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5.06 g  in 67.50 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 40018 g  in 67.50 g
GLYCERIN20.41 g  in 67.50 g
PROPYLENE GLYCOL15 g  in 67.50 g
WATER5.4 mL  in 67.50 g
POLYSORBATE 200.66 g  in 67.50 g
CARBOMER 9400.357 g  in 67.50 g
TROLAMINE0.287 g  in 67.50 g
ALCOHOL0.09 mL  in 67.50 g
MENTHOL0.024 g  in 67.50 g
SUCRALOSE0.006 g  in 67.50 g
D&C RED NO. 330.0027 g  in 67.50 g
Product Characteristics
ColorredScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63240-5001-21 in 1 BOX
1NDC:63240-5001-167.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/2000
SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63240-5002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5.07 g  in 67.5 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 40018 g  in 67.5 g
GLYCERIN20.27 g  in 67.5 g
PROPYLENE GLYCOL15 g  in 67.5 g
WATER5.4 mL  in 67.5 g
POLYSORBATE 200.66 g  in 67.5 g
CARBOMER 9400.357 g  in 67.5 g
TROLAMINE0.287 g  in 67.5 g
SUCRALOSE0.006 g  in 67.5 g
FD&C YELLOW NO. 50.000252 g  in 67.5 g
FD&C RED NO. 400.00003 g  in 67.5 g
FD&C BLUE NO. 10.000006 g  in 67.5 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorBUTTERSCOTCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63240-5002-21 in 1 BOX
1NDC:63240-5002-167.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/2000
SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63240-5003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5.07 g  in 67.5 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 40018 g  in 67.5 g
GLYCERIN20.86 g  in 67.5 g
PROPYLENE GLYCOL15 g  in 67.5 g
WATER5.4 mL  in 67.5 g
POLYSORBATE 200.66 g  in 67.5 g
CARBOMER 9400.357 g  in 67.5 g
TROLAMINE0.287 g  in 67.5 g
SUCRALOSE0.006 g  in 67.5 g
FD&C RED NO. 400.00054 g  in 67.5 g
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63240-5003-21 in 1 BOX
1NDC:63240-5003-167.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/2005
Labeler - Eau Zone Oils and Fragrances LTD (249543091)
Establishment
NameAddressID/FEIBusiness Operations
Eau Zone Oils and Fragrances LTD249543091manufacture(63240-5000), label(63240-5000, 63240-5001, 63240-5002, 63240-5003)

Revised: 2/2013
Document Id: 22162b5f-c013-47c2-9da6-4ffd75779a47
Set id: 58ed1a91-3f33-48b8-be00-52cd08a55ee3
Version: 1
Effective Time: 20130227
 
Eau Zone Oils and Fragrances LTD