SHUNGA SENSATION BALM- benzocaine gel 
Eau Zone Oils and Fragrances LTD
Reference Label Set Id: 53799c84-0749-40df-9582-44a1d08665e6

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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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 Type HUMAN OTC DRUG Item Code (Source) NDC:63240-5000
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5.07 g  in 67.50 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 18 g  in 67.50 g
GLYCERIN (UNII: PDC6A3C0OX) 20.86 g  in 67.50 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 15 g  in 67.50 g
WATER (UNII: 059QF0KO0R) 5.4 g  in 67.50 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.66 g  in 67.50 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.357 g  in 67.50 g
TROLAMINE (UNII: 9O3K93S3TK) 0.287 g  in 67.50 g
SUCRALOSE (UNII: 96K6UQ3ZD4) 0.006 g  in 67.50 g
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0027 g  in 67.50 g
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0003 g  in 67.50 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 g  in 67.50 g
Product Characteristics
Color red Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63240-5000-2 1 in 1 BOX
1 NDC:63240-5000-1 67.5 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 01/01/2000
SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63240-5001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5.06 g  in 67.50 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 18 g  in 67.50 g
GLYCERIN (UNII: PDC6A3C0OX) 20.41 g  in 67.50 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 15 g  in 67.50 g
WATER (UNII: 059QF0KO0R) 5.4 mL  in 67.50 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.66 g  in 67.50 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.357 g  in 67.50 g
TROLAMINE (UNII: 9O3K93S3TK) 0.287 g  in 67.50 g
ALCOHOL (UNII: 3K9958V90M) 0.09 mL  in 67.50 g
MENTHOL (UNII: L7T10EIP3A) 0.024 g  in 67.50 g
SUCRALOSE (UNII: 96K6UQ3ZD4) 0.006 g  in 67.50 g
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0027 g  in 67.50 g
Product Characteristics
Color red Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63240-5001-2 1 in 1 BOX
1 NDC:63240-5001-1 67.5 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 01/01/2000
SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63240-5002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5.07 g  in 67.5 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 18 g  in 67.5 g
GLYCERIN (UNII: PDC6A3C0OX) 20.27 g  in 67.5 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 15 g  in 67.5 g
WATER (UNII: 059QF0KO0R) 5.4 mL  in 67.5 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.66 g  in 67.5 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.357 g  in 67.5 g
TROLAMINE (UNII: 9O3K93S3TK) 0.287 g  in 67.5 g
SUCRALOSE (UNII: 96K6UQ3ZD4) 0.006 g  in 67.5 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.000252 g  in 67.5 g
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.00003 g  in 67.5 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.000006 g  in 67.5 g
Product Characteristics
Color white Score     
Shape Size
Flavor BUTTERSCOTCH Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63240-5002-2 1 in 1 BOX
1 NDC:63240-5002-1 67.5 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 01/01/2000
SHUNGA  SENSATION BALM
benzocain gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63240-5003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5.07 g  in 67.5 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 18 g  in 67.5 g
GLYCERIN (UNII: PDC6A3C0OX) 20.86 g  in 67.5 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 15 g  in 67.5 g
WATER (UNII: 059QF0KO0R) 5.4 mL  in 67.5 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.66 g  in 67.5 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.357 g  in 67.5 g
TROLAMINE (UNII: 9O3K93S3TK) 0.287 g  in 67.5 g
SUCRALOSE (UNII: 96K6UQ3ZD4) 0.006 g  in 67.5 g
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.00054 g  in 67.5 g
Product Characteristics
Color pink Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63240-5003-2 1 in 1 BOX
1 NDC:63240-5003-1 67.5 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 01/01/2005
Labeler - Eau Zone Oils and Fragrances LTD (249543091)
Establishment
Name Address ID/FEI Business Operations
Eau Zone Oils and Fragrances LTD 249543091 manufacture(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