Orajel Cold Sore Touch Free - Single Dose

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:57:24

Label at a glance#

ProductOrajel Cold Sore Touch Free - Single Dose
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE
Label structure9 sections

Indications and uses

to treat cold sores/fever blisters

Dosage and administration

•slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride

Benzocaine

Purpose

OTC - PURPOSE SECTION

Benzalkonium chloride 0.13% ...................................................Topical Antiseptic

Benzocaine 5% .........................................................................Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

to treat cold sores/fever blisters

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame. Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ​•pale, gray, or blue colored skin (cyanosis) •headache •rapid heart rate •shortness of breath •dizziness or lightheadedness •fatigue or lack of energy​

Allergy alert:do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

OTC - DO NOT USE SECTION

Do not use•in the eyes •over large areas of the body •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a dentist or physician if•condition persists or worsens •symptoms persist for more than 7 days

OTC - ASK DOCTOR SECTION

Ask a physician if•used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby

OTC - WHEN USING SECTION

When using this productyou may feel a brief stinging when you apply it. The sting should go away in a short time.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

•slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin •to treat most cold sores, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick

Adults and children 2 years of age and olderDo not use more than 3 times per day
Children between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this product
Children under 2 years of ageDo not use

Other information

OTHER SAFETY INFORMATION

•store at room temperature • the ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in this product •for best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for at least one hour after applying the drug •do not use if package is torn, cut or otherwise damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

isopropyl alcohol (70% v/v), water

Questions or comments?

OTC - QUESTIONS SECTION

call us at 1-800-952-5080M-F 9am-5pm ET or visit our website at www.orajel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

LOOK

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

BONUS

50% MORE

Orajel™

COLD SORE

PROVIDES IMMEDIATE, TARGETED PAIN RELIEF

LIQUID

FORMULA

TOPICAL ANTISEPTIC

TOPICAL ANESTHETIC

CONTAINS 6 TREATMENT VIALS

NET 0.12 FL OZ (3.5 mL) TOTAL

Orajel Touch Free Cold Sore - Six Vials.jpgOrajel Touch Free Cold Sore - Six Vials.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2572114benzalkonium chloride 0.13 % / benzocaine 5 % Topical SolutionPSN6
2572114benzalkonium chloride 1.3 MG/ML / benzocaine 50 MG/ML Topical SolutionSCD6
2572114benzalkonium chloride 0.13 % / benzocaine 5 % Topical SolutionSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130310310998943GTIN-13: 0310310998943
EAN-13: 0310310998943
GTIN-12: 310310998943
UPC-A: 310310998943
GTIN storage (14 digits): 00310310998943
Orajel Touch Free Cold Sore - Six Vials.jpg

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-798-35Orajel Cold Sore Touch Free - Single Dose3.5 mL in 1 VIAL, SINGLE-DOSELIQUID3.56
10237-798-35Orajel Cold Sore Touch Free - Single Dose6 in 1 PACKAGELIQUID66

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-79810237-798-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-11monthly-update2026-06-03 17:45:45

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
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
ndc (package): 10237-798-35
ndc (product): 10237-798
ndc11 (package): 10237079835
spl id: 51b6fb8e-eeba-a04a-e063-6294a90a610f
spl set id: ce40829e-941f-2548-e053-2995a90a1e0e

Reported adverse events (FAERS/openFDA)#

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