Indications and uses
USES to treat cold sores / fever blisters
USES to treat cold sores / fever blisters
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. ...
ACTIVE INGREDIENTS
Benzalkonium chloride, 0.13%
Benzocaine, 5%
PURPOSE
Topical Antiseptic
USES
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
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
In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.
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
INACTIVE INGREDIENTS
isopropyl alcohol (70% v/v), water
Questions or comments call us at 1 800 952 5080 Monday through Friday ET or visit our website at www orajel com
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
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZALKONIUM CHLORIDE | ACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| BENZALKONIUM | ACTIVE MOIETY | 7N6JUD5X6Y | 1 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10237-756 | 10237-756-04, 10237-756-03 |
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 |
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 | SPONGE / TOPICAL | 4 %w/w | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SWAB / TOPICAL | 43.9 %w/w | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | OIL / TOPICAL | 72 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | OIL / AURICULAR (OTIC) | 6 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 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL, METERED / TOPICAL | 525 mg |
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 |
|---|---|---|---|---|---|---|
| d7723392-c3a1-1bb4-e053-2995a90af3d6 | 05efbe22-2fed-42e3-a181-65558805cb2a | 2022-02-07 | Warnings | d7723392-c3a1-1bb4-e053-2995a90af3d6 05efbe22-2fed-42e3-a181-65558805cb2a |
Adverse event summaries are temporarily unavailable. Other product information remains available.