Search by Drug Name or NDC
NDC 63240-5100-02 Shunga 1.125 g/15g Details
Shunga 1.125 g/15g
Shunga is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Eau Zone Oils & Fragrances LTD. The primary component is BENZOCAINE.
Product Information
| NDC | 63240-5100 |
|---|---|
| Product ID | 63240-5100_ed0d9b0f-8f7d-df7d-e053-2a95a90a7a38 |
| 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 | Male Genital Desensitizer |
| Non-Proprietary Name | Benzocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | AEROSOL, SPRAY |
| Route | TOPICAL |
| Active Ingredient Strength | 1.125 |
| Active Ingredient Units | g/15g |
| Substance Name | BENZOCAINE |
| Labeler Name | Eau Zone Oils & 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 63240-5100-02 (63240510002)
| NDC Package Code | 63240-5100-2 |
|---|---|
| Billing NDC | 63240510002 |
| Package | 1 BOTTLE, SPRAY in 1 CYLINDER (63240-5100-2) / 15 g in 1 BOTTLE, SPRAY (63240-5100-1) |
| Marketing Start Date | 2010-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 413d0f4c-e7fc-4299-8a06-503c9dfb02c6 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Name: SHUNGA Genital Desensitizer
SHUNGA Male Genital Desensitizer helps in temporarily prolonging the time until ejaculation by diminishing tactile sensations to the penis.
Directions: Spray 3 to 8 doses on the head and shaft of the penis, between 5 to 10 minutes prior to activity. The effective number of sprays and application delay may vary upon individuals. Use the minimum effective quantity. (Consult the booklet for additional information).
Purpose
Male genital desensitizer
Uses
It helps in temporarily prolonging the time until ejaculation by diminishing tactile sensations to the penis. Use for reducing oversensitivity in advance of intercourse.
Directions
Spray 3 to 8 doses on the head and shaft of the penis, between 5 to 15 minutes prior to intercourse. The effective number of sprays and application delay may vary upon individuals. Use the minimum effective quantity. Wash off after intercourse.
Other information
Store below 25ºC (77ºF). Each spray application contains 7.0 mg of Benzocaine and there are about 170 spray doses per container.
SPL UNCLASSIFIED SECTION
Directions
Warnings
FOR EXTERNAL USE ONLY
When using this product. Avoid contact with eyes; in case of contact with eyes flush with water. Do not exceed a maximum of 24 sprays in 24 hours. Do not inhale.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.
Uses
INGREDIENTS AND APPEARANCE
| SHUNGA
MALE GENITAL DESENSITIZER
benzocaine aerosol, spray |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Eau Zone Oils & Fragrances LTD (249543091) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Eau Zone Oils & Fragrances LTD | 249543091 | manufacture(63240-5100) , label(63240-5100) | |