Orajel for Cold Sores
- Manufacturer
- Church & Dwight Co., Inc. | James Alexander Corporation | Berkeley Contract Packaging, LLC
- Effective date
- 2012-04-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:46:49
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
Cold Sore / Fever Blister Treatment; Topical Antiseptic
Pain Relief During Applications
INDICATIONS & USAGE SECTION
WARNINGS SECTION
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 the product
- more than 3 times per day
- longer than one week unless directed by a physician
- condition persists or worsens
- symptoms persist for more than 7 days
- used to treat deep or puncture wounds, animal bites, or serious burns
- you are pregnant or nursing a baby
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUR 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
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.
OTHER INFORMATION
- Store at room temperature
- The ingredients in toothpaste, soft drinks, and some fruit juices can
de-activate 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
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZALKONIUM CHLORIDE | ACTIVE INGREDIENT | F5UM2KM3W7 | 2 | |
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 2 | |
| BENZALKONIUM | ACTIVE MOIETY | 7N6JUD5X6Y | 2 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 2 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Orajel for Cold Sores Single Dose
- Benzalkonium Chloride, Benzocaine
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- BENZOCAINE
- ISOPROPYL ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-741 | 10237-741-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL, METERED / TOPICAL | 525 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | OIL / AURICULAR (OTIC) | 6 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | OIL / TOPICAL | 72 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SWAB / TOPICAL | 43.9 %w/w | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SOLUTION / TOPICAL | 40 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SPONGE / TOPICAL | 4 %w/w |
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 |
|---|---|---|---|---|---|---|
| 96252c55-8028-3482-e053-2a95a90a1d50 | d0c9a69f-c0fe-4feb-928b-7dc4602185a5 | 2019-10-30 | Warnings | d0c9a69f-c0fe-4feb-928b-7dc4602185a5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

