FDA.reportPublic FDA data

Zilactin-B

Manufacturer
ASCENT CONSUMER PRODUCTS, INC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:42:22

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 yearsadult supervision should be given in the use of this product
children under 2 yearsdo 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

OTC - QUESTIONS SECTION

Call 1-888-547-5492

Distributed by Ascent Consumer Products

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZBZB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198488benzocaine 10 % Oral GelPSN1
1542803zilactin-B 10 % Oral GelPSN1
1542803benzocaine 0.1 MG/MG Oral Gel [Zilactin B]SBD1
198488benzocaine 0.1 MG/MG Oral GelSCD1
198488benzocaine 10 % Oral GelSY1
1542803Zilactin B 0.1 MG/MG Oral GelSY1
1542803Zilactin-B 10 % Mucosal GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42829-550-32Zilactin-B7 g in 1 TUBEGEL71
42829-550-32Zilactin-B1 in 1 CARTONGEL11

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
42829-55042829-550-32

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 (TYPE M)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
Zilactin-BBENZOCAINEASCENT CONSUMER PRODUCTS, INC42eeb3d4-bac6-4e29-e063-6294a90a644d2025-11-06WarningsExact identifier
ndc (package): 42829-550-32
ndc (product): 42829-550
ndc11 (package): 42829055032
spl id: 42eec176-84ad-1e81-e063-6394a90afd01
spl set id: 42eeb3d4-bac6-4e29-e063-6294a90a644d

Reported adverse events (FAERS/openFDA)#

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