Orajel for Cold Sores

Manufacturer
Team Technologies, Inc
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:06:49

Label at a glance#

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Benzalkonium chloride, 0.13%
Benzocaine, 5%

OTC - PURPOSE SECTION

PURPOSE

Topical Antiseptic
Pain Reliever

INDICATIONS & USAGE SECTION

USES

  • to treat cold sores / fever blisters

WARNINGS SECTION

WARNINGS

For external use only. Flammable, keep away from fire or flame.

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

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.

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.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS
Adults and children over 2 years of age:

  • Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using only warm water or alcohol
  • 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, usually one treatment is enough.  If your symptoms go away and then return later, apply another dose for the second cold sore
  • Do not use more than 3 times per day
  • Discard after use.

Children under 2 years of age: ask a dentist or physician.

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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS
isopropyl alcohol (70% v/v), water

OTC - QUESTIONS SECTION

Questions or coments? call us at 1-800-952-5080 M-F ET or visit our website at www.orajel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orajel
Instant Pain Relief

FOR COLD SORES

Serious Relief for Serious Cold Sores

SINGLE DOSE

Patented Cold Sore Treatment

Topical Antiseptic/Topical Anesthetic

Touch-Free Applicator

OJBC-38403-02OJBC-38403-02

OJBC-99881-01AOJBC-99881-01A

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
67659-15067659-150-25
10237-756

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

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
b4507cca-9b35-20aa-e053-2a95a90a8d0a3c13e246-9175-7314-e054-00144ff8d46c2020-11-17WarningsExact identifier
spl id: b4507cca-9b35-20aa-e053-2a95a90a8d0a
spl set id: 3c13e246-9175-7314-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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