NDC 57483-003
EJECTDELAY Gel
Benzocaine 7.5%
EJECTDELAY Gel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Innovus Pharmaceuticals, Inc.. The primary component is Benzocaine.
| Product ID | 57483-003_8ed5ea44-59d6-4851-8fa6-e8babc69206a |
| NDC | 57483-003 |
| Product Type | Human Otc Drug |
| Proprietary Name | EJECTDELAY Gel |
| Generic Name | Benzocaine 7.5% |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2013-07-15 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part333B |
| Labeler Name | Innovus Pharmaceuticals, Inc. |
| Substance Name | BENZOCAINE |
| Active Ingredient Strength | 8 g/100g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 57483-003-02
1 TUBE in 1 BOX (57483-003-02) > 56.8 g in 1 TUBE (57483-003-03)
| Marketing Start Date | 2013-07-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 57483-003-03 [57483000303]
EJECTDELAY Gel GEL
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-07-15 |
NDC 57483-003-01 [57483000301]
EJECTDELAY Gel GEL
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-07-15 |
| Marketing End Date | 2013-08-07 |
NDC 57483-003-08 [57483000308]
EJECTDELAY Gel GEL
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-07-15 |
| Inactivation Date | 2020-01-31 |
NDC 57483-003-06 [57483000306]
EJECTDELAY Gel GEL
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-07-19 |
| Inactivation Date | 2020-01-31 |
NDC 57483-003-07 [57483000307]
EJECTDELAY Gel GEL
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-07-15 |
| Inactivation Date | 2020-01-31 |
NDC 57483-003-02 [57483000302]
EJECTDELAY Gel GEL
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-07-15 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 7.5 g/100g |
OpenFDA Data
| SPL SET ID: | 24a9e4e5-a418-43a2-890f-7f90cd5f5b3f |
| Manufacturer | |
| UNII |
Trademark Results [EJECTDELAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EJECTDELAY 85914704 4593829 Live/Registered |
Innovus Pharmaceuticals, Inc. 2013-04-25 |
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