Zilactin

Manufacturer: Blairex Laboratories, Inc.
Effective date: 2025-11-25
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: monthly-update
Hydrated at: 2026-06-03 17:40:47

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 contact1-800-252-4739

Websitewww.zilactin.com

www.zilactin.com

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

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROMOTES HEALING

Cold Sore/Fever Blister/Oral Pain Treatment

Zilactin ^® Early Relief Cold Sore Gel

Bioadhesive Promotes Healing
Relieves Pain for up to 6 Hours

Net wt. 0.25 oz (7.1g)

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0350486468024	GTIN-13: 0350486468024 EAN-13: 0350486468024 GTIN-12: 350486468024 UPC-A: 350486468024 GTIN storage (14 digits): 00350486468024	zil01-0002-02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50486-468-02	GM - Gram	50486-468	feeb987b-10e2-4d18-aee3-432e07a602e5	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
benzyl alcohol	ACTIVE INGREDIENT	LKG8494WBH	1
benzyl alcohol	ACTIVE MOIETY	LKG8494WBH	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	1
eucalyptol	INACTIVE INGREDIENT	RV6J6604TK	1
Hydroxypropyl Cellulose (Type M)	INACTIVE INGREDIENT	U3JF91U133	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
salicylic acid	INACTIVE INGREDIENT	O414PZ4LPZ	1
tannic acid	INACTIVE INGREDIENT	28F9E0DJY6	1
thymol	INACTIVE INGREDIENT	3J50XA376E	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50486-468	50486-468-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
THYMOL	3J50XA376E	IACT
MENTHOL	L7T10EIP3A	IACT
TANNIC ACID	28F9E0DJY6	IACT
WATER	059QF0KO0R	IACT
BENZYL ALCOHOL	LKG8494WBH	ACTIB
BORIC ACID	R57ZHV85D4	IACT
HYDROXYPROPYL CELLULOSE (TYPE M)	U3JF91U133	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
ALCOHOL	3K9958V90M	IACT
EUCALYPTOL	RV6J6604TK	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 190 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	INJECTION, SOLUTION / INTRAVENOUS		210 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	SOLUTION / OPHTHALMIC		60 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
eucalyptol	EUCALYPTOL	RV6J6604TK	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
eucalyptol	EUCALYPTOL	RV6J6604TK	DROPS / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 7 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	SOLUTION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates

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
44708d21-d3ce-cabe-e063-6294a90a97b6			0910d0d8-dc69-43bb-967d-08cab8ae917b	2025-11-25	Warnings	Exact identifier spl id: 44708d21-d3ce-cabe-e063-6294a90a97b6 spl set id: 0910d0d8-dc69-43bb-967d-08cab8ae917b

Reported adverse events (FAERS/openFDA)#

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