FDA.reportPublic FDA data

Zilactin-B

Manufacturer
Applied Laboratories, Inc.
Effective date
2021-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:25:18

Label at a glance#

ProductZilactin-B
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 10%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain caused by:

  • canker sores
  • minor mouth sores and gum irritations
  • denture and brace pain

Warnings

WARNINGS SECTION

Flammable:

SPL UNCLASSIFIED SECTION

  • keep away from fire or flame

Allergy Alert:

SPL UNCLASSIFIED SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

Boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 38-B, tannic acid

Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA

OTC - QUESTIONS SECTION

TelephoneTelephoneQuestions or Comments?
Call TOLL FREE 1-800-252-4739
www.zilactin.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROMOTES HEALING

Oral Pain Reliever

Zilactin ®-B 6 Hour Canker & Mouth Sore Relief

  • Bioadhesive Promotes Healing
  • Eat and Drink Pain-Free for up to 6 Hours

Net wt. 0.25 oz (7g)

Principal Display Panel
Principal Display Panel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72751-030272751-0302-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)U3JF91U133IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SALICYLIC ACIDO414PZ4LPZIACT
ALCOHOL3K9958V90MIACT
PEPPERMINT OILAV092KU4JHIACT
TANNIC ACID28F9E0DJY6IACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d21c544c-39da-0bb8-e053-2995a90ac6a2e0ebcdbb-a75a-4a10-8686-457484fabe2d2021-12-01WarningsExact identifier
spl id: d21c544c-39da-0bb8-e053-2995a90ac6a2
spl set id: e0ebcdbb-a75a-4a10-8686-457484fabe2d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.