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NDC 63240-5001-02 Shunga 5.06 g/67.5g Details

Shunga 5.06 g/67.5g

Shunga is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Eau Zone Oils and Fragrances LTD. The primary component is BENZOCAINE.

Product Information

NDC	63240-5001
Product ID	63240-5001_ed0da60a-e089-0be7-e053-2a95a90a7a82
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Shunga
Proprietary Name Suffix	Sensation Balm
Non-Proprietary Name	Benzocain
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	5.06
Active Ingredient Units	g/67.5g
Substance Name	BENZOCAINE
Labeler Name	Eau Zone Oils and Fragrances LTD
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63240-5001-02 (63240500102)

Pricing Information	N/A
NDC Package Code	63240-5001-2
Billing NDC	63240500102
Package	1 JAR in 1 BOX (63240-5001-2) / 67.5 g in 1 JAR (63240-5001-1)
Marketing Start Date	2000-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 58ed1a91-3f33-48b8-be00-52cd08a55ee3 Details

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHUNGA SENSATION BALM

benzocain gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63240-5000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.07 g in 67.5 g

Ingredient Name	Strength
Inactive Ingredients
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 g 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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0027 g in 67.5 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.0003 g in 67.5 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0001 g in 67.5 g

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63240-5000-2	1 in 1 BOX	01/01/2000
1	NDC:63240-5000-1	67.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.06 g in 67.5 g

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	18 g in 67.5 g
GLYCERIN (UNII: PDC6A3C0OX)	20.41 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
ALCOHOL (UNII: 3K9958V90M)	0.09 mL in 67.5 g
MENTHOL (UNII: L7T10EIP3A)	0.024 g in 67.5 g
SUCRALOSE (UNII: 96K6UQ3ZD4)	0.006 g in 67.5 g
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0027 g in 67.5 g

Product Characteristics
Color	red	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63240-5001-2	1 in 1 BOX	01/01/2000
1	NDC:63240-5001-1	67.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.07 g in 67.5 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63240-5002-2	1 in 1 BOX	01/01/2000
1	NDC:63240-5002-1	67.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.07 g in 67.5 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63240-5003-2	1 in 1 BOX	01/01/2005
1	NDC:63240-5003-1	67.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part348	01/01/2005

Labeler - Eau Zone Oils and Fragrances LTD (249543091)

Name	Address	ID/FEI	Business Operations
Establishment
Eau Zone Oils and Fragrances LTD		249543091	manufacture(63240-5000) , label(63240-5000, 63240-5001, 63240-5002, 63240-5003)

Revised: 11/2022

Document Id: ed0da60a-e089-0be7-e053-2a95a90a7a82

Set id: 58ed1a91-3f33-48b8-be00-52cd08a55ee3

Version: 3

Effective Time: 20221109

Search by Drug Name or NDC

NDC 63240-5001-02 Shunga 5.06 g/67.5g Details

Shunga 5.06 g/67.5g

Product Information

Package

Package Images

NDC 63240-5001-02 (63240500102)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 58ed1a91-3f33-48b8-be00-52cd08a55ee3 Details

Active ingredient

Warnings

Directions

Stop use and ask doctor if

Warning

Purpose

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

Directions

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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