Label: SHUNGA SENSATION BALM- benzocaine gel 

  • Label RSS
  • NDC Code(s): 63240-5000-1, 63240-5000-2, 63240-5001-1, 63240-5001-2, view more
    63240-5002-1, 63240-5002-2, 63240-5003-1, 63240-5003-2
  • Packager: Eau Zone Oils and Fragrances LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Male Desensitizing Gel

    Gel désensibilisant mâle

    Active Ingredient
    Benzocaine 7.5 pourcentage

    Genital Desensitizer
    Désensibilisant Genital


    Benzocaine USP 7.5 pourcent

    60ml

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

    Close
  • INGREDIENTS AND APPEARANCE
    SHUNGA  SENSATION BALM
    benzocain gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63240-5000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 5.07 g  in 67.50 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 18 g  in 67.50 g
    GLYCERIN 20.86 g  in 67.50 g
    PROPYLENE GLYCOL 15 g  in 67.50 g
    WATER 5.4 g  in 67.50 g
    POLYSORBATE 20 0.66 g  in 67.50 g
    CARBOMER 940 0.357 g  in 67.50 g
    TROLAMINE 0.287 g  in 67.50 g
    SUCRALOSE 0.006 g  in 67.50 g
    D&C RED NO. 33 0.0027 g  in 67.50 g
    FD&C RED NO. 40 0.0003 g  in 67.50 g
    FD&C BLUE NO. 1 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 LABEL Item Code (Source) NDC:63240-5001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 5.06 g  in 67.50 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 18 g  in 67.50 g
    GLYCERIN 20.41 g  in 67.50 g
    PROPYLENE GLYCOL 15 g  in 67.50 g
    WATER 5.4 mL  in 67.50 g
    POLYSORBATE 20 0.66 g  in 67.50 g
    CARBOMER 940 0.357 g  in 67.50 g
    TROLAMINE 0.287 g  in 67.50 g
    ALCOHOL 0.09 mL  in 67.50 g
    MENTHOL 0.024 g  in 67.50 g
    SUCRALOSE 0.006 g  in 67.50 g
    D&C RED NO. 33 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 LABEL Item Code (Source) NDC:63240-5002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 5.07 g  in 67.5 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 18 g  in 67.5 g
    GLYCERIN 20.27 g  in 67.5 g
    PROPYLENE GLYCOL 15 g  in 67.5 g
    WATER 5.4 mL  in 67.5 g
    POLYSORBATE 20 0.66 g  in 67.5 g
    CARBOMER 940 0.357 g  in 67.5 g
    TROLAMINE 0.287 g  in 67.5 g
    SUCRALOSE 0.006 g  in 67.5 g
    FD&C YELLOW NO. 5 0.000252 g  in 67.5 g
    FD&C RED NO. 40 0.00003 g  in 67.5 g
    FD&C BLUE NO. 1 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 LABEL Item Code (Source) NDC:63240-5003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 5.07 g  in 67.5 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 18 g  in 67.5 g
    GLYCERIN 20.86 g  in 67.5 g
    PROPYLENE GLYCOL 15 g  in 67.5 g
    WATER 5.4 mL  in 67.5 g
    POLYSORBATE 20 0.66 g  in 67.5 g
    CARBOMER 940 0.357 g  in 67.5 g
    TROLAMINE 0.287 g  in 67.5 g
    SUCRALOSE 0.006 g  in 67.5 g
    FD&C RED NO. 40 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)
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