Zilactin

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 Early Relief Cold Sore

Active ingredientBENZYL ALCOHOL

Label structure10 sections

Dosage and administration

adults and children 2 years and older dry affected area. Apply 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

Contacts and useful links#

PhoneLabel contact1-888-547-5492

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzyl alcohol 10%

Purpose

OTC - PURPOSE SECTION

Cold sore/fever blister treatment, Oral pain reliever

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain caused by:

cold sores/fever blisters
canker sores, mouth sores
gum irritations

Warnings

WARNINGS SECTION

Flammable:

SPL UNCLASSIFIED SECTION

keep away from fire or flame

Stop use and ask a physician if

OTC - STOP USE SECTION

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

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 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 to film, and immediately wipe the area with a moist gauze pad or tissue.
contains alcohol 68% 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 37, tannic acid

OTC - QUESTIONS SECTION

Call 1-888-547-5492

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581456	benzyl alcohol 10 % Oral Gel	PSN	1
866357	zilactin Early Relief Cold Sore 10 % Oral Gel	PSN	1
866357	benzyl alcohol 0.1 ML/ML Oral Gel [Zilactin Cold Sore]	SBD	1
581456	benzyl alcohol 0.1 ML/ML Oral Gel	SCD	1
581456	benzyl alcohol 10 % Mucous Membrane Topical Gel	SY	1
866357	Zilactin Cold Sore 0.1 ML/ML Oral Gel	SY	1
866357	Zilactin Cold Sore 10 % Oral Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZYL ALCOHOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42829-468-02	ZilactinEarly Relief Cold Sore	7 g in 1 TUBE	GEL	7		1
42829-468-02	ZilactinEarly Relief Cold Sore	1 in 1 CARTON	GEL	1		1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Zilactin Early Relief Cold Sore
benzyl alcohol
TANNIC ACID
WATER
BORIC ACID
HYDROXYPROPYL CELLULOSE (TYPE M)
PROPYLENE GLYCOL
SALICYLIC ACID
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42829-468	42829-468-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TANNIC ACID	28F9E0DJY6	IACT
WATER	059QF0KO0R	IACT
BORIC ACID	R57ZHV85D4	IACT
HYDROXYPROPYL CELLULOSE (TYPE M)	U3JF91U133	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
ALCOHOL	3K9958V90M	IACT
BENZYL ALCOHOL	LKG8494WBH	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zilactin Early Relief Cold Sore	BENZYL ALCOHOL	ASCENT CONSUMER PRODUCTS, INC	42ef8bfa-c4d9-01cf-e063-6394a90ac88a	2025-11-06	Warnings	Exact identifier ndc (package): 42829-468-02 ndc (product): 42829-468 ndc11 (package): 42829046802 spl id: 42ef8c05-236d-12e9-e063-6394a90ae7d1 spl set id: 42ef8bfa-c4d9-01cf-e063-6394a90ac88a

Reported adverse events (FAERS/openFDA)#

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