Orajel Instant Pain Relief MAXIMUM Toothache Oral Pain Relief
- Manufacturer
- Swabplus, L.P.
- Effective date
- 2021-05-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:44:45
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Benzocaine 20%
Purpose
Oral Pain Reliever
Use
For the temporary relief due to
- toothaches
- canker sores
- minor injury of the mouth and gums
- minor irritation of the mouth and gums caused by dentures
Warnings
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
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
ASK DOCTOR
Stop use and ask a physician if:
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
KEEP OUT OF REACH OF CHILDREN
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
Directions -
Adults and children 2 years of age and over -
- Hold swab with solid white tip down
- Bend and snap open swab tip with the colored rings
- Apply product to the cavity and around gum surrounding the teeth
- Use up to 4 times daily or as directed by a physician or healthcare provider
- Discard swab after application
Children under 12 years of age - Should be supervised in the use of this product
Children under 2 years of age - Ask a physician or healthcare provider
Other Information
- do not use if label seal is broken prior to purchase or if the colored rings on tip are not blue
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
Inactive Ingredients
flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5
Questions or Comments?
call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at
WWW.ORAJEL.COM
Orajel Instant Pain Relief MAXIMUM
Touch-Free Applicator
#1 Oral Pain Reliever for Toothache
Orajel
Instant Pain Relief
MAXIMUM
Toothache & Oral Pain Relief
20% Benzocaine to Relieve Oral Pain
Toothache Canker Sores
Gum Pain Denture Pain
Cheek Bites
ORAL PAIN RELIEVER 12-UNIT DOSE SWABS 0.06 FL. OZ (1.8ML) TOTAL SINGLE-USE SWABS
Products#
Every source-derived product name is available through these pages.
- Orajel Instant Pain Relief MAXIMUM Toothache Oral Pain Relief
- Benzocaine
- POLYETHYLENE GLYCOL 1000
- WATER
- METHYL SALICYLATE
- SACCHARIN SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65734-502 | 65734-502-12 |
| 10237-755 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
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 |
|---|---|---|---|---|---|---|
| c25366f9-4e9e-4200-e053-2995a90a94cd | c25366f9-4e9d-4200-e053-2995a90a94cd | 2021-05-14 | Warnings | c25366f9-4e9e-4200-e053-2995a90a94cd c25366f9-4e9d-4200-e053-2995a90a94cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
