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NDC 50486-0468-02 Zilactin 0.1 g/g Details
Zilactin 0.1 g/g
Zilactin is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Blairex Laboratories, Inc.. The primary component is BENZYL ALCOHOL.
Product Information
NDC | 50486-0468 |
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Product ID | 50486-468_d17aea84-0bb2-8ff1-e053-2a95a90adf21 |
Associated GPIs | 88350012004010 |
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 | Zilactin |
Proprietary Name Suffix | Early Relief Cold Sore |
Non-Proprietary Name | benzyl alcohol |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | 0.1 |
Active Ingredient Units | g/g |
Substance Name | BENZYL ALCOHOL |
Labeler Name | Blairex Laboratories, Inc. |
Pharmaceutical Class | Pediculicide [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 50486-0468-02 (50486046802)
NDC Package Code | 50486-468-02 |
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Billing NDC | 50486046802 |
Package | 1 TUBE in 1 CARTON (50486-468-02) / 7.1 g in 1 TUBE |
Marketing Start Date | 2005-06-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0910d0d8-dc69-43bb-967d-08cab8ae917b Details
Use
Warnings
Stop use and ask a physician if
- sore mouth symptoms do not improve in 7 days
- condition worsens or symptoms clear up and occur again within a few 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
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ZILACTIN
EARLY RELIEF COLD SORE
benzyl alcohol gel |
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Labeler - Blairex Laboratories, Inc. (092575133) |
Revised: 11/2021
Document Id: d17aea84-0bb2-8ff1-e053-2a95a90adf21
Set id: 0910d0d8-dc69-43bb-967d-08cab8ae917b
Version: 4
Effective Time: 20211123