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NDC 00404-0018-35 Benzo Jel 11.4 g/57g Details
Benzo Jel 11.4 g/57g
Benzo Jel is a DENTAL SPRAY, METERED in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein Inc.. The primary component is BENZOCAINE.
Product Information
| NDC | 00404-0018 |
|---|---|
| Product ID | 0404-0018_d58f5916-cfd7-20a4-e053-2995a90a0d8d |
| 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 | Benzo Jel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY, METERED |
| Route | DENTAL |
| Active Ingredient Strength | 11.4 |
| Active Ingredient Units | g/57g |
| Substance Name | BENZOCAINE |
| Labeler Name | Henry Schein Inc. |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00404-0018-35 (00404001835)
| NDC Package Code | 0404-0018-35 |
|---|---|
| Billing NDC | 00404001835 |
| Package | 57 g in 1 BOTTLE, SPRAY (0404-0018-35) |
| Marketing Start Date | 2016-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2cd571fc-30ee-40da-a2c7-25adb7d4b5c3 Details
Uses
Warnings
Flammable. Do not use near fire or flame. Avoid smoking during use.
Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Stop use and ask a doctor if
- you experience any of the following symptoms:
- weakness
- confusion
- headache
- difficulty breathing
- pale, grey or blue colored skin as these may be signs of methemoglobinemai, a rare disorder, which may appear up to two hours after use.
Keep out of reach of children.
Dosage
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
| BENZO JEL
benzocaine spray, metered |
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| Labeler - Henry Schein Inc. (012430880) |
Revised: 1/2022
Document Id: d58f5916-cfd7-20a4-e053-2995a90a0d8d
Set id: 2cd571fc-30ee-40da-a2c7-25adb7d4b5c3
Version: 4
Effective Time: 20220114