cut open tip of tube on score mark Adults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 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
www.orajel.comBenzocaine 20%
Menthol 0.26%
Oral pain reliever
for the temporary relief of pain due to toothaches
Methemogloblnemla 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 rate
■ 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, butacalne, benzocaine or other "caine" anesthetics
Do not use ■ more than directed ■ for more than 7 days unless directed by a dentist
or doctor ■ for teething ■ in children under 2 years of age
Stop use and ask a doctor if ■ symptoms do not improve in 7 days ■ swelling, rash
or fever develops ■ irrnation, pain or redness persists or worsens
Keep out of reach of children. In case of overdose or allergic reaction, get medical
help or contact a Poison Control Center right away
Adults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctor
Children between 2 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
■ do not use if tube tip is cut prior to opening ■ this preparation is intended for use in cases of toothache, only as temporary expedient
until a physician can be consulted
ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
call us at
1-800-952-5080 M-F 9am-5pm ET or visit our website at
www.orajel.com
ORAJEL TM
2X TOOTHACHE & GUM MEDICATED
IMMEDIATE PAIN RELIEF
ORAL PAIN RELIEVER
GEL
NET WT 0.25 OZ (7.0 g)
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-782-25 | Orajel 2X Medicated Gel | 7 g in 1 TUBE | GEL | 7 | 1 | |
| 10237-782-25 | Orajel 2X Medicated Gel | 1 in 1 CARTON | GEL | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10237-782 | 10237-782-25 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| SODIUM SACCHARIN | SB8ZUX40TY | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| SORBIC ACID | X045WJ989B | IACT |
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 |
|---|---|---|---|---|---|---|
| Orajel 2X Medicated Gel | ORAL PAIN RELIEVER | Church & Dwight Co., Inc. | 262be295-4eaf-3136-e063-6294a90a7dcc | 2024-11-05 | Warnings | 10237-782-25 10237-782 10237078225 262be295-4eb0-3136-e063-6294a90a7dcc 262be295-4eaf-3136-e063-6294a90a7dcc |
Adverse event summaries are temporarily unavailable. Other product information remains available.