Search by Drug Name or NDC
NDC 50486-0550-32 Zilactin-B 0.1 g/g Details
Zilactin-B 0.1 g/g
Zilactin-B is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Blairex Laboratories, Inc.. The primary component is BENZOCAINE.
Product Information
| NDC | 50486-0550 |
|---|---|
| Product ID | 50486-550_d17abbc0-8870-6c82-e053-2995a90a5940 |
| Associated GPIs | 88350010004030 |
| GCN Sequence Number | 003480 |
| GCN Sequence Number Description | benzocaine GEL (GRAM) 10 % MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 12209 |
| HICL Sequence Number | 001516 |
| HICL Sequence Number Description | BENZOCAINE |
| Brand/Generic | Generic |
| Proprietary Name | Zilactin-B |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | benzocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 0.1 |
| Active Ingredient Units | g/g |
| Substance Name | BENZOCAINE |
| Labeler Name | Blairex Laboratories, 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 | 2024-12-31 |
Package
Package Images
NDC 50486-0550-32 (50486055032)
| NDC Package Code | 50486-550-32 |
|---|---|
| Billing NDC | 50486055032 |
| Package | 1 TUBE in 1 CARTON (50486-550-32) / 7 g in 1 TUBE |
| Marketing Start Date | 2005-06-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 34ce5d91-35ff-4f2c-9d6b-ac389895b6b2 Details
Use
Warnings
Allergy Alert:
- do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics
Stop use and ask a physician if
- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- apply only to affected area
- do not exceed recommended dosage
- avoid contact with the eyes
- do not use for more than 7 days unless directed by a physician or dentist
Directions
| adults and children
2 years and older | Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. |
| children under 12 years | adult supervision should be given in the use of this product |
| children under 2 years | do not use, consult a physician or dentist |
Other information
- do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin-B Long Lasting Mouth Sore Gel to film, and immediately wipe the area with a moist gauze pad or tissue.
- contains alcohol 65% by volume
- store at 15-30°C (59-86°F)
Inactive ingredients
Questions or Comments?
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| ZILACTIN-B
benzocaine gel |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Blairex Laboratories, Inc. (092575133) |
Revised: 11/2021
Document Id: d17abbc0-8870-6c82-e053-2995a90a5940
Set id: 34ce5d91-35ff-4f2c-9d6b-ac389895b6b2
Version: 4
Effective Time: 20211123