Orajel for Cold Sores

Manufacturer
Church & Dwight Co., Inc.
Effective date
2022-02-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:09:12

Label at a glance#

ProductOrajel for Cold Sores Single Dose
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE
Label structure13 sections

Indications and uses

USES to treat cold sores / fever blisters

Dosage and administration

Directions • 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. ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Benzalkonium chloride, 0.13%

Benzocaine, 5%

Purpose

OTC - PURPOSE SECTION

PURPOSE

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

USES

  • to treat cold sores / fever blisters

Warnings

WARNINGS SECTION

WARNINGS

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 beat, 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

Do not use

OTC - DO NOT USE SECTION

  • 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 one week unless directed by a physician
    • for teething
    • in children under 2 years of age

Stop use and ask a dentist or physician if

OTC - STOP USE SECTION

  • condition persists or worsens
  • symptoms persist for more than 7 days

Ask a physician if

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

You may feel a brief stinging sensation when you apply it.  The sting should go away in a short time.

Keep out of reach of children

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

Directions

• 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 results ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick

Adults and children over 2 years of age: Do not use this more than 3 times per day

Children between 2 year and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age: Do not use







OTHER INFORMATION

  • Store at room temperature
  • The ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in Orajel Single Dose.
  • For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.
  • Do not use if package is torn, cut or otherwise damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

isopropyl alcohol (70% v/v), water

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments call us at 1 800 952 5080 Monday through Friday ET or visit our website at www orajel com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast-Acting

Orajel™ Instant Pain Relief

Coldsore

Patented Treatment

Topical Antiseptic/

Topical Anethetic

Contains 4 treatment vials

NET 0.08 FL OZ (2.4mL) Total

OJBC-99881-04.jpgOJBC-99881-04.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
BENZOCAINEACTIVE MOIETYU3RSY48JW51
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

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
10237-75610237-756-04, 10237-756-03

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

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 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d7723392-c3a1-1bb4-e053-2995a90af3d605efbe22-2fed-42e3-a181-65558805cb2a2022-02-07WarningsExact identifier
spl id: d7723392-c3a1-1bb4-e053-2995a90af3d6
spl set id: 05efbe22-2fed-42e3-a181-65558805cb2a

Reported adverse events (FAERS/openFDA)#

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