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#
Contacts and useful links#
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
- 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
- condition persists or worsens
- symptoms persist for more than 7 days
Ask a physician if
- used to treat deep or puncture wounds, animal bites, or serious burns
- you are pregnant or nursing a baby
When using this product
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
Products#
Every source-derived product name is available through these pages.
- Orajel for Cold Sores Single Dose
- Benzalkonium Chloride, Benzocaine
- ISOPROPYL ALCOHOL
- WATER
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- BENZOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67659-150 | 67659-150-25 |
| 10237-756 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b4507cca-9b35-20aa-e053-2a95a90a8d0a | 3c13e246-9175-7314-e054-00144ff8d46c | 2020-11-17 | Warnings | b4507cca-9b35-20aa-e053-2a95a90a8d0a 3c13e246-9175-7314-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

